Recommendations Post-COVID Vaccination

Getting the Covid-19 vaccination shouldn’t change any of your typical health, fitness, or wellness routines, or at least not for more than a day or two. Still, it’s reasonable to have questions about whether you should hold off on certain things, such as working out, drinking alcohol, or taking certain medications. Below are some of the common questions people have about what they should or shouldn’t do after vaccination related to their own health.

Medications

A common circulating question is whether it’s okay to take painkillers and fever reducers, such as acetaminophen (Tylenol) or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin. In the big Covid-19 vaccine FAQ on Elemental, the CDC does not recommend taking any of these medications before vaccination for the sake of preventing fever, headache, or other aches. Physicians advise against it because limited evidence suggests it could blunt your body’s immune response.

Basically, wait until you get the vaccine, see what happens and how you feel, and if you experience fever, headache, or other pains, take your preferred painkiller/fever reducer then. There is no evidence to suggest taking acetaminophen or an NSAID after vaccination will negatively affect your immune response.

If you take any immunosuppressive medications, such as biologics for autoimmune diseases, or you’re receiving treatments for cancer, it’s best to check with your specialist (your oncologist, immunologist, rheumatologist, etc.) to find out if you need to skip any doses or wait to get vaccinated between cycles of medications or treatments. Not much data exists on the vaccine and immunosuppressive medication so far, so you’ll need to rely on your physician’s clinical expertise and what we know about other types of vaccines.

Exercise

No specific recommendations exist related to exercise after getting the Covid-19 vaccine. It’s all going to depend on how you feel. If you’re feeling tired from the vaccine, especially if you have muscle cramps or aches, skip the workout until they subside. Your body is telling you that you need rest, and your immune system probably needs the rest to do its job. If you have the stronger side effects of fever, chills, or fatigue, you should definitely wait until they pass before going for a run or doing a set of deadlifts. If you exercise at a class, it’s probably best not to schedule one in the first two days after each vaccine dose until you know how you’re feeling.

However, if you’re feeling fine, you can try physical activity in a day or two afterward as long as you start slowly and pay attention to your body. You might not have immediately felt any side effects, but once you start exerting yourself, you might find you tire more quickly or easily in the first few days after vaccination. Some physicians advise against any exercise in the first 24 hours after the vaccine, but that’s based more on a “take it easy and see how it goes” approach rather than any data showing that exercise could harm you or the vaccine response.

Drink Alcohol

Yes, you can, but it’s still not the best idea to consume alcohol in the first 24 to 48 hours after vaccination. First, you’re likely to feel tired or achy from the vaccine already, especially if it’s your second dose of one of the mRNA vaccines, so adding a toxin like alcohol to your body when it’s in the process of learning to fight off a specific pathogen could make you feel worse. Alcohol also contributes to dehydration, leading to headaches and muscle or joint pain.

Light Therapy After the Vaccine?

Of course, use red light therapy to improve your circadian rhythm to boost your recovery process. You can use red and infrared light if you feel your body sore and tired.

Build Immunity

Most of the vaccines require two doses. You aren’t automatically immune the day after you get your second dose of an mRNA vaccine. Your body needs time to detect the foreign substance in your body, identify it as an intruder, and build up antibodies to fight it. That takes about two weeks, so consider yourself truly, fully immunized two weeks after your second dose.

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Light Therapy Can Help COVID-19 Patients Recover Faster

Light Therapy Can Help COVID-19 Patients Recover Faster

We all know what COVID-19 is, and many of us have had to deal with it ourselves. As much as the pandemic has slowed in many places, the world is far from going back normal. The struggle is not only in the disease, but the massive shift that it’s brought in the world. 

And there is such variance on the effect the virus can have if you do catch it – some people experience no symptoms, while others could fall into a critical state;  though the general consensus is that most COVID patients experience a string of similar symptoms, ranging from mild to extreme. Fever and coughing are some of the first symptoms patients experience, next to the infamous loss of smell and taste. While in some way, it presents itself much like a common cold, in many other ways, the symptoms can be stronger, long-lasting, and more intense.

We’ve even accepted that it’s normal to not fully recover immediately. Like with any virus, recovery often depends on a person’s immune system. It’s not a surprise that some people take much longer to get back to their optimal health once the COVID-19 virus sets it back for them. Many people have stated that even weeks or months after getting over the virus, they don’t feel fully recovered. 

As much as it is a unique experience for each person, certain symptoms and effects can linger after contracting COVID-19. Primarily what could remain affected are lungs, and studies suggest even the brain. Next to that, obviously, your immune system and overall health are affected.

Among the post-COVID symptoms reported are fatigue, brain fog, joint pain. chest pain, heart palpitations, headaches, dizziness, and insomnia — and these are all after people have technically “recovered” from the primary infection.

While recovering from COVID takes time, there are some things you can do to improve the healing process – taking immune supplements such as vitamin C and echinacea, getting ample rest, and, yes, with light therapy. 

The benefits of light therapy are vast, and the treatment has been proven to help improve overall well-being by amplifying cell turnover rate. Working deep at the cellular level, light therapy gives people the chance to rejuvenate their cells into healthier and stronger ones that can ultimately lead to overall better health. 

Light therapy creates and accelerates the release of ATP; this is what fuels our body, so it’s not surprising athletes use this form of therapy to not only heal their wounds and bodies but also refuel their muscles.  

So how can light therapy exactly help with COVID symptoms? Well, there have been studies to show that progress is accelerated with the aid of light therapy. What’s even better is that light-based technologies are currently cost-effective and widely available in the market. So, investing in a light therapy device can significantly improve your health without breaking the bank.

Photons can also be used to deactivate SARS-CoV-2 in air, liquids, and on surfaces. Phototherapy can be used as an aid to control virus infection and to modulate the host immune system. Light-based solutions can significantly contribute to mitigating the impacts of COVID-19 pandemic.

Light therapy use has been used for decades,  so it’s no surprise that doctors are implementing it now during these conditions. Light therapy essentials include using different lights to help with different problems, red light being the most commonly used. Light therapy can help improve the immune system by increasing the health and production rate of cells overall. It also helps with circadian rhythm, shifting us into the best schedule and sleep state and allowing our bodies to rest and recover better.  Brain fog and chronic fatigue are some of the COVID symptoms that can be improved via light therapy treatment as it aids with restoring sleep patterns, and reduces inflammation in the body. 

Studies show that through light therapy, your general wellness and overall health improves which can result in deep body healing, and accelerated recovery from symptoms caused by COVID-19. 


Thankfully, Kaiyan Medical produces MDA-certified and FDA-approved light therapy devices perfect for your own at-home treatment, or even for your patients. We’re honored to be able to provide solutions for both patients and healthcare practitioners for this virus that we’ve all been affected by in one way or another – and we’re confident that light therapy will continue to show incredible results for those affected by people across the globe.


Recommendations Post-COVID Vaccination

Recommendations Post-COVID Vaccination

Getting the Covid-19 vaccination shouldn’t change any of your typical health, fitness, or wellness routines, or at least not for more than a day or two. Still, it’s reasonable to have questions about whether you should hold off on certain things, such as working out, drinking alcohol, or taking certain medications. Below are some of the common questions people have about what they should or shouldn’t do after vaccination related to their own health.

Medications

A common circulating question is whether it’s okay to take painkillers and fever reducers, such as acetaminophen (Tylenol) or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or aspirin. In the big Covid-19 vaccine FAQ on Elemental, the CDC does not recommend taking any of these medications before vaccination for the sake of preventing fever, headache, or other aches. Physicians advise against it because limited evidence suggests it could blunt your body’s immune response.

Basically, wait until you get the vaccine, see what happens and how you feel, and if you experience fever, headache, or other pains, take your preferred painkiller/fever reducer then. There is no evidence to suggest taking acetaminophen or an NSAID after vaccination will negatively affect your immune response.

If you take any immunosuppressive medications, such as biologics for autoimmune diseases, or you’re receiving treatments for cancer, it’s best to check with your specialist (your oncologist, immunologist, rheumatologist, etc.) to find out if you need to skip any doses or wait to get vaccinated between cycles of medications or treatments. Not much data exists on the vaccine and immunosuppressive medication so far, so you’ll need to rely on your physician’s clinical expertise and what we know about other types of vaccines.

Exercise

No specific recommendations exist related to exercise after getting the Covid-19 vaccine. It’s all going to depend on how you feel. If you’re feeling tired from the vaccine, especially if you have muscle cramps or aches, skip the workout until they subside. Your body is telling you that you need rest, and your immune system probably needs the rest to do its job. If you have the stronger side effects of fever, chills, or fatigue, you should definitely wait until they pass before going for a run or doing a set of deadlifts. If you exercise at a class, it’s probably best not to schedule one in the first two days after each vaccine dose until you know how you’re feeling.

However, if you’re feeling fine, you can try physical activity in a day or two afterward as long as you start slowly and pay attention to your body. You might not have immediately felt any side effects, but once you start exerting yourself, you might find you tire more quickly or easily in the first few days after vaccination. Some physicians advise against any exercise in the first 24 hours after the vaccine, but that’s based more on a “take it easy and see how it goes” approach rather than any data showing that exercise could harm you or the vaccine response.

Drink Alcohol

Yes, you can, but it’s still not the best idea to consume alcohol in the first 24 to 48 hours after vaccination. First, you’re likely to feel tired or achy from the vaccine already, especially if it’s your second dose of one of the mRNA vaccines, so adding a toxin like alcohol to your body when it’s in the process of learning to fight off a specific pathogen could make you feel worse. Alcohol also contributes to dehydration, leading to headaches and muscle or joint pain.

Light Therapy After the Vaccine?

Of course, use red light therapy to improve your circadian rhythm to boost your recovery process. You can use red and infrared light if you feel your body sore and tired.

Build Immunity

Most of the vaccines require two doses. You aren’t automatically immune the day after you get your second dose of an mRNA vaccine. Your body needs time to detect the foreign substance in your body, identify it as an intruder, and build up antibodies to fight it. That takes about two weeks, so consider yourself truly, fully immunized two weeks after your second dose.

Light Therapy & Sleep Quality:  The Secret of the Chinese Female Basketball Players

Light Therapy & Sleep Quality: The Secret of the Chinese Female Basketball Players

Good sleep is a prerequisite for optimal performance. Given that people spend about one-third of their lives asleep, sleep has substantial development, daily functioning, and health. Perhaps no daytime behavior has been associated more closely with improved sleep than exercise. Researchers have shown that exercise serves as a positive function for sleep. Regular exercise consistently has been associated with better sleep. Moreover, the American Academy of Sleep Medicine considers physical exercise a modality of nonpharmacologic treatment for sleep disorders. When studying the influence of exercise on sleep, most investigators have compared acute and sedentary control treatments. In the study of regular moderate-intensity endurance exercise, researchers also provided compelling evidence that exercise promotes sleep.

However, exercise can negatively affect sleep quality. Exercising immediately before going to sleep is detrimental to sleep quality. Athletes train very hard to improve their on-field performances, but excessive training may decrease performance, known as overtraining syndrome. Researchers have shown that symptoms of overtraining indicate poor-quality sleep. Good sleep is an important recovery method for the prevention and treatment of overtraining in sports practice.

In a recent study in which red-light therapy (wavelength = 670 nm, light dose = 4 J/cm2) was used, researchers indicated that red light could restore glutathione redox balance upon toxicologic insult enhance both cytochrome c oxidase and energy production, all of which may be affected by melatonin. Melatonin is a neurohormone that is produced by the pineal gland and regulates sleep and circadian functions. No one knows whether sleep is regulated by melatonin after red-light irradiation in athletes. Researchers have demonstrated that phototherapy improves muscle regeneration after exercise. A red light could protect human erythrocytes in preserved diluted whole blood from the damage caused by experimental artificial heart-lung machines.

Participants

Twenty female athletes of the Chinese People’s Liberation Army team (age = 18.60 ± 3.60 years) participated in the study. All participants were healthy and were not using medications regularly or temporarily during the measurements. Athletes were excluded if they had participated in less than 80% of the scheduled team physical training and basketball sessions for the last 3 months or used any nutritional supplements or pharmacologic agents. All participants provided written informed consent, and the Ethical Committee approved the China Institute of Sport Science study.

Design

Participants were assigned randomly to either a red-light therapy intervention group (n = 10) or non–red-light therapy intervention group (placebo group, n = 10). Measurements were collected at preintervention (baseline) and postintervention (14 days). The exercise training schedule of the 2 groups was unchanged during the 14 days; the red-light treatment group used a red-light therapy instrument every night for total body irradiation for 30 minutes. The training routine of the athletes during the 14 intervention days included 12 exercise sessions with the following specifications: 2 hours of morning training, 2 hours of afternoon training, and no training on Sunday.

The red-light treatment participants lay in the supine position. Continuous illumination was performed using noncoherent red light from a whole-body red-light treatment machine-like Kaiyan’s red light therapy bed, with an average wavelength of 658 nm and a light dose of 30 J/cm2. The whole body received the phototherapy treatment. The placebo participants also lay in the supine position under the red-light device but did not receive any light illumination. All participants wore swimsuits to enhance irradiation from the device and were blind to the treatment.


Measurement

Sleep Quality

The Chinese version of the PSQI measured sleep quality. The 19-item measure assesses sleep quality and disturbances over a half-month time interval. The total PSQI score ranges from 0 to 21, and higher scores reflect poorer-quality sleep. The 7 items of this instrument measure several aspects of insomnia: difficulties with onset and maintenance of sleep, satisfaction with the current sleep pattern, interference with daily functioning, noticeable impairment attributed to sleep problems, degree of distress, and concern caused by any sleeping problems.

Cooper 12-Minute Run

Participants were instructed to complete as many laps as possible on a 400-m outdoor track during the 12-minute test period. Emphasis was placed on pacing oneself throughout the test. The test administrators counted the laps completed during the 12-minute test period while calling out the time elapsed at 3, 6, and 9 minutes and orally encouraging the participants. At the end of the 12-minute period, the test administrator instructed the participants to stop and used a measuring wheel to determine the fraction of the last lap completed by each participant. This distance was added to the distance determined by the number of laps completed to give the total distance covered during the test.

Serum Melatonin

In humans, the serum level of melatonin, derived mainly from the pineal gland, demonstrates a clear increase at night and a decrease during the day. Given that the masking effects of activities (e.g., exercise, sleep, and food intake) have little effect on the circulating melatonin level's daily pattern, melatonin secretion appears to directly reflect the function of the biological clock as a specific marker of the circadian rhythm.

Conclusions

The study has demonstrated that red-light illumination positively affected sleep quality and endurance performance variables in Chinese female basketball players. Based on previous studies, we can infer that red-light treatment contributes to increased melatonin secretion in the pineal gland and muscle regeneration. Although more studies involving phototherapy, sleep, and exercise performance need to be performed, red-light treatment is a possible nonpharmacologic and noninvasive therapy to prevent sleep disorders after training.

Acknowledgments

This research project was supported by the National Key Technologies R&D Program Fund of China (2006BAK37B06).

Originally from:


Red Light and the Sleep Quality and Endurance Performance of Chinese Female Basketball Players

Jiexiu Zhao, Ye Tian, Jinlei Nie, Jincheng Xu, Dongsen Liu

J Athl Train. 2012 Nov-Dec; 47(6): 673–678. doi: 10.4085/1062-6050-47.6.08

PMCID: PMC3499892

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Light Therapy Proves Effective in COVID-19 Treatment Once Again

Light Therapy Proves Effective in COVID-19 Treatment Once Again

Even though we’ve been in the pandemic for over a year now, we are still collecting knowledge on the disease. No one could’ve prepared us for the impact of this virus, and COVID-19 has changed our lives forever. 

It is a disease caused by the coronavirus, and the symptoms are similar, but people react differently. It isn’t a virus that gives the same outcome, which is why we have to be so cautious with it. Most common symptoms include fever and dry cough, and extreme fatigue. Apart from those, the other major symptoms are a loss of smell and taste, joint pain, diarrhea, conjunctivitis, and headaches.

Scientists and doctors have learned that respiratory problems are the biggest issue while having the disease. The downfall of our immune system during COVID-19 is what gives a chance for pneumonia to develop. Apart from those symptoms and the dangers of getting pneumonia, there’s also potential long-term effects. 

So far, only one peer-reviewed study has reported results on the long-term symptoms of COVID-19 infection: a single group of 143 survivors from Rome. Most of them did not need hospitalization and were assessed at least 60 days after infection. They reported a worsened quality of life in 44.1% of cases, including symptoms of persistent fatigue (53.1%), breathlessness (43.4%), joint pain (27.3%), and chest pain (21.7%).

Treatment has evolved within this short period, and now with the vaccine in power, it poses a question: is it the only solution? It's still necessary to nourish our immune system no matter what; intake of vitamins and supplements is still highly advised. But naturally, aside from the vaccine, you would want a non-invasive alternative as well, which is where light therapy comes into play.

Red light therapy is a non-invasive and non-pharmaceutical method of treatment. It works with light that emits at a close, safe distance, penetrating into the cells. Once it reaches cell level, it helps reproduce ATP, which gives a higher and better cell turnout. 

Our cells rejuvenate and reproduce themselves; light therapy only aids in this natural process. With light therapy, we get a better and higher count of cells that are genetically improved over time with treatment. 

The ways in which light therapy can help with COVID-19 have been studied for a while now, and we shared some information on early clinical trials with you previously. 

Light therapy can help with COVID-19 in reducing severity and prominence of symptoms; it works so that light therapy generates the activation of mitochondrial antiviral signaling protein (MAVS), thus resulting in the reduced expression of viral spike protein and restores the proliferation of infected cells.

Your cells are healing your body by using light therapy––similar to how UV light therapy aids wound healing––and it is there to provide you with more vital cells for your system. A significant reduction of viral infection in the trachea was noticed, the spots where we notice symptoms first, such as our nose and our throats. This means that light therapy helps regulate and decrease the possibility of getting a respiratory disease like pneumonia. 

A significantly smaller level of C-reactive protein was observed within seven days of UVA therapy regarding biochemical parameters. It proves that light therapy helps with the deconstruction of damaging proteins in our cells. 

Photo-disinfection is used to get rid of harmful bacteria from surgical patients; this is only another form of that. There's also a method where a non-toxic dye is inserted into the nose. It is one that is triggered by light, and then it is measured whether or not the light therapy device has successfully inactivated the virus. This method is used in the early stages of COVID-19.

The one used in the beforehand mentioned study included a light therapy device equipped with a multi-LED UVA light catheter connected to the nasal tube to deliver UVA light to the patients. Our devices are created with multi-LED, so the type of light therapy is your choice, depending on your needs.

The UVA therapy was administered for 20 minutes to all patients once daily for 5 consecutive days. Before the treatment, all patients received oxygen supplementation for 30 minutes. The regimen varies however light therapy should be done consecutively and 10 to 15 minutes.

The coronavirus is still here, but you’re not defenseless. Kaiyan Medical works to develop the best high-quality light therapy devices, with FDA-approved and MDA-certified light therapy devices perfect for at-home treatments. Whether you’re looking to bolster your immune system or wish to provide non-invasive treatment to patients with COVID-19, light therapy is an incredibly powerful and effective tool in fighting the serious symptoms of this virus.

Conducting a Well-Controlled Clinical Trial for the FDA

Conducting a Well-Controlled Clinical Trial for the FDA

In a scientific experiment, the tighter the controls on the experiment’s variables are, the more accurate and insightful the research’s findings will be. It’s the same case for clinical trials in the life sciences industry. A well-controlled clinical trial rooted in the scientific method's foundation will produce more reliable data and conclusions.

But how do you define a “well-controlled” clinical trial? Much to the relief of the life sciences manufacturers and their research teams, the U.S. Food and Drug Administration (FDA) provides explicit guidance on what it means to conduct an adequate and well-controlled clinical trial in 21 CFR 314.126.

What Is a Clinical Trial?

According to clinicaltrials.gov, in a clinical trial (also called an interventional study), participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or medical devices, procedures, or changes to participants’ behavior — for example, diet.

What’s the Difference Between Medical Device Clinical Trials and Drug Trials?

Many of the same factors that make a well-controlled clinical trial for medical devices are similar to what makes a well-controlled drug trial. Still, there are some fundamental differences researchers need to know.

Key differences between medical device trials versus drug trials include:

  • Differences in the Subjects who Participate. In most drug trials, the drug is tested on a small group of healthy individuals first, then administered to incrementally larger populations. Medical device trials typically only involve subjects with the condition for which the trial is designed.
  • Differences in who Administers Drugs versus Devices. In a drug trial, the patient or patient’s caregiver is typically the person who administers the drug. In a medical device trial, the person administering the device is typically the principal investigator.
  • Differences in who has Greater Responsibility. In a drug trial, the patient typically has a higher responsibility for taking the drug as required. In a device trial, the physician shares a greater part of ensuring the device is operated correctly.
  • Differences in Training Requirements. Because the physician has a greater responsibility to administer medical devices correctly, a medical device trial typically requires more practical experience — such as training in cadaver labs or proctoring during live cases.
  • Differences in the FDA Approval Process. The approval process for new drugs is typically longer than the approval process for medical devices. While it takes 12 years on average to bring a new drug to market, the average length of time it takes to bring a medical device to market is three to seven years. However, this does not always mean it’s easier to obtain approval for a new medical device. The extent of the approval process and whether a medical device requires premarket approval depends on its classification. Medical devices determined to carry significant risks to human subjects generally require premarket approval.

Which FDA Regulations Are Required in a Clinical Trial?

Both drug and device trials follow the same requirements for protecting human subjects, maintaining records, and disclosing financial relationships. Those requirements include:

  • 21 CFR 11 — Electronic medical records.
  • 21 CFR 50 — Human subject protection.
  • 21 CFR 54 — Financial disclosure.
  • 21 CFR 56 — Institutional Review Board (IRB) requirements.

While drug trials are required to follow 21 CFR 312, medical device trials are governed by 21 CFR 812.

What Makes A Well-Controlled Clinical Trial?

Whether it’s a drug trial or a medical device trial, the FDA makes it clear that all trials should have the following:

  • A clear statement of the investigation's objectives and a summary of the proposed methods of analysis in the protocol.
  • A design that permits a valid comparison with control to provide a quantitative assessment of the effect.
  • The subject selection provides adequate assurance that the subject has the disease or condition that the treatment is directed at.
  • A method of assigning patients to treatment and control groups minimizes bias and assures the groups' comparability.
  • Adequate measures to minimize bias by the subjects, observers, and data analysts.
  • Well-defined and reliable assessment of subjects’ responses.
  • Analysis of the results is adequate to assess the effect of the drug or device.

The experiment variables are designed to prove or disprove a causal relationship between the independent and dependent variables. This would be the drug or device versus the condition of the patient.

Control is a vital element of a well-designed experiment of the main variables. There needs to be a way to rule out the effects of extraneous variables other than the dependent and independent ones.

A good experiment, like a good clinical trial, often has blind controls or double-blind randomization to compare the results. The goal for a well-controlled experiment is for it to be repeated many times with the same or statistically similar results. Clinical trials are typically not repeated as much as they are designed with large numbers of subjects to remove the bias in a study with small subject sampling. This helps to rule out random samples or outliers in the “experiment.”

Many would argue other things go into the makeup of a well-controlled clinical trial, especially once sites and patients get involved. Having a research team with adequate facilities, knowledge of the federal regulations, and the time and staff to work on the project are also imperative. Additionally, having timely, well-documented data is vital to the trial’s continued success, which helps ensure the trial is being conducted in a way that will produce relevant results.

What Can We Do To Conduct Well-Controlled Clinical Trials?

A well-controlled clinical trial starts with a strong understanding of the risks involved and proper planning to mitigate those risks. Today, it increasingly requires deep knowledge of FDA regulations and global requirements like the European Union’s Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) requirements.

Managing the many risks of any trial and keeping it moving forward requires diligent monitoring, record-keeping, and seamless coordination between all parties involved.

Finally, as clinical trials wind down, researchers need to ensure they have all the correct documentation in order in their trial master file.

A full-service contract research organization (CRO) with expertise in conducting global clinical trials is invaluable when conducting a well-controlled clinical trial. They can assist with clinical planning and consulting before a trial begins. They can help with monitoring, auditing, project management, and safety management during the trial. And they can ensure all your documents are in order as you wrap up a trial so you can obtain approval.

FDA Premarket Requirements

Bringing a device to the market in the United States may appear complex. Following these four steps may assist you in navigating the process:

1) Classify Your Device and Understand Applicable Controls

The first step in preparing a marketing device in the United States is to determine how the FDA has classified your device. A medical device is defined by law in section 201(h) of the Federal Food, Drug and Cosmetic (FD&C) Act.

Medical devices are categorized into three classes (I, II, or III) based on the degree of risk they present. As device class increases from class I to class II to class III, the regulatory controls also increase, with class I devices subject to the least regulatory control and class III devices subject to the most stringent regulatory control.

2) Select and Prepare the Correct Premarket Submission

You should select and prepare the appropriate premarket submission if required for your specific product’s classification. For most medical devices, the appropriate submission type is identified within the product classification, which may be obtained from the public Product Classification database. Note some device types do not require a premarket submission. The most common types of premarket submissions include:

  • 510(k) (Premarket Notification)
  • PMA (Premarket Approval)
  • De Novo Classification Request
  • HDE (Humanitarian Device Exemption)

510(k)

Some class I and most Class II devices require a 510(k). In a 510(k), the sponsor must demonstrate that the new device is “substantially equivalent” to a predicate device in terms of intended use, technological characteristics, and performance testing, as needed.

Some class I and class II devices are exempt from the 510(k) notification requirement if they do not exceed the exemption limitations stated in 21 CFR xxx.9, where xxx refers to 21CFR 862–892.

PMA

Class III devices require a PMA. A PMA is the most stringent type of premarket submission. Before the FDA approves a PMA, the sponsor must provide valid scientific evidence demonstrating reasonable assurances of safety and effectiveness for the device’s intended use.

De Novo Classification Request

The De Novo process provides a pathway to classify novel medical devices for which general controls alone, general and special controls, provide reasonable assurance of safety and effectiveness for the intended use. Still, there is no legally marketed predicate device.

HDE

HDE provides a regulatory pathway for class III devices intended to benefit patients with rare diseases or conditions. For a device to be eligible for an HDE, a sponsor must first obtain designation as a Humanitarian Use Device (HUD).

3) Prepare the Appropriate Information for the Premarket Submission

Once you have prepared the appropriate premarket submission for your device, you need to send your submission to the FDA and interact with FDA staff during its review. Before sending your submission to the FDA, you should be aware of the following:

  • Medical Device User Fees: There is a user fee associated with the submission of certain marketing applications.
  • Small Business Determination (SBD) Program: A qualified and certified business as a “small business” is eligible for substantially reducing most of these user fees.
  • eCopy: Premarket submissions must include an electronic copy (eCopy) on a compact disc (CD), digital video disc (DVD), or a flash drive.

Once the FDA has received your submission, you should be aware of the following:

  • Administrative Review: After a premarket submission is received, the FDA conducts an administrative review to assess whether the submission is sufficiently complete to be accepted for substantive review.
  • Interactive Review: While submission is under review, the FDA staff communicates with applicants to increase the review process's efficiency. Step Four: Comply with Applicable Regulatory Controls, Including Establishment Registration and Device Listing

Regulatory controls are risk-based requirements that apply to medical devices and give the FDA the oversight to ensure medical devices' reasonable safety and effectiveness.

How Light Therapy Enhances Physical Therapy Treatment

How Light Therapy Enhances Physical Therapy Treatment

Though laser technology started with Albert Einstein, the technology didn’t evolve until the 1960’s when a laser prototype at Hughes Research Laboratories in Malibu, California, was first built. However, its purpose wasn’t for the medical industry; instead, for the military.

It eventually trickled down into Hollywood when Sci-Fi directors realized its potential for visual effects. But, of course, it didn’t take long for other fields to jump on the laser light bandwagon, including the medicine and rehabilitation industries. From there, the medical industry began to understand laser light’s impact on the human body when it came to healing and recovery.

Low-level (light) laser therapy (LLLT) is used to treat various conditions, including pain relief and inflammation. Over the past ten years, research and technological advancements have fine-tuned low-level light therapy, making the treatment highly effective in providing pain relief and healing treatment.

What is Low-Level Laser Light Therapy?

Before we talk about its capabilities, it’s essential to understand how it functions. Low-level laser light therapy is a non-invasive technique that gives the body a low dose of light to stimulate cellular healing. Laser light therapy targets the specific area in need to increase mobility by reducing pain and inflammation.

Low-level laser light therapy works through a process called photobiomodulation. During this process, the light is absorbed by the body’s tissue, where the cells respond with a physiological reaction, promoting cellular regeneration. The light stimulates cellular metabolism to promote cell growth and the healing of damaged cells.

How Laser Light Affects the Body

There are a couple of ways laser light therapy affects the body. Here’s what laser light therapy does for the body:

  1. Light energy is absorbed by melanin, hemoglobin, and water. The energy dissolves into heat, creating a soothing and warm sensation. The warming sensation helps patients feel relaxed.
  2. There’s an increase in ATP production in the mitochondria through light energy, the cell’s powerhouse. With increased ATP production, more energy is available for the healing process.
  3. Light energy aids with the release of nitric oxide, which enhances the circulation of damaged tissue. Increased circulation allows for improved oxygen exchange, nutrient exchange, and waste removal.
  4. Light energy releases crucial chemicals that help reduce inflammation.

So can laser light therapy be used alongside physical therapy? The answer is yes. In fact, the two treatments complement each other perfectly.

The Perfect Pair: Laser Light Therapy and Physical Therapy

With patients experiencing chronic or acute pain, the feeling of pain isn’t the main issue. However, patients can reduce pain and inflammation symptoms through laser light therapy while undergoing physical therapy treatments. Laser light therapy is ideal for pre and post-surgical procedures and during rehabilitation.

Patients undergoing laser light therapy will feel warm and soothing healing sensations as well as an immediate reduction in pain after treatment. By reducing pain, patients will improve their physical therapy performance and reduce their healing time. Ideally, four to six laser light therapy sessions are recommended to patients to receive the best results.

Whether you’re looking to improve your chiropractic, dermatology, medical or physical therapy practice, laser light therapy can provide your patients with the extra care they need to reduce chronic or acute pain and inflammation symptoms.

With many laser light products on the market, you want to make sure you’re investing in a medical-grade laser light device for your practice. Kaiyan Medical manufactures MDA-certified and FDA-approved laser light therapy devices, ideal for various medical and rehabilitation industries.

Private Label Your Dream Light Therapy Product with Kaiyan

Private Label Your Dream Light Therapy Product with Kaiyan

Whether you’re a dermatologist, physical therapist, fitness enthusiast or just someone considering integrating light therapy into their practice, you’ve likely heard about the multitude of benefits that these non-invasive yet powerful devices offer. As light therapy continues to gain popularity, more professionals are looking for light therapy devices to level up. 

Naturally, you can purchase professional devices from light therapy companies, but you can also develop a light therapy device that can be customized to fit your individual client’s needs. This is where we, Kaiyan Medical, come in to help guide you through the process of producing your very own private label light therapy products at our state-of-the-art manufacturing facility. 

If you’re interested in creating your own light therapy products, it’s crucial you understand the development process.

The Steps of Private Label Product Development

We want our clients to comprehend the creative and manufacturing process of developing private label light therapy devices. As this is your idea we’re bringing to life, you need to be included every step of the way. Here’s our step-by-step process:

Step 1: Feasibility Study

It’s easy to lose money by investing in a product without understanding user needs. If you don’t know your target audience, you’ll struggle to create a viable product. During the feasibility step, we determine the practicality of your project and examine its strengths and weaknesses. This helps to ensure the idea you want to bring to life is viable and effective in achieving its goal. 

Step 2: Industrial Design

With our advanced conceptual design team, we determine how we can best engage with your target audience. While we focus on design, we also make sure your device fits under the required safety and health regulations. Our in-house design process creates visually appealing, high-quality, and functional concepts for manufacturing and product planning. 

Step 3: Electrical Engineering

Our in-house team has vast experience in lasers, sourcing, prototyping, and LEDs to incorporate these components and masterfully develop your product. Our electrical engineers, who are in charge of this step, take your idea and bring it to life while ensuring high-quality performance. 

Step 4: Rapid Prototyping

Rapid prototyping is essential for our projects and allows the client to see and feel their idea in the palm of their hands. In addition, it also helps clients test products with their users and receive constructive feedback. Our rapid prototyping is completed in-house as we have the capacity to create a range of samples varying from simple to complex, multi-piece models. 

Step 5: Mass Production

After your idea is turned into a tangible product and has been tested, we then plan production with in-house, pre-pilot quantities. By doing so, we’re able to identify production areas that need to be fine-tuned while ensuring high-quality and performance standards. Once these steps are completed, your product will be ready for shipment. Through our vast experience and stellar team, we can ensure a smooth manufacturing process and will guide you each step along the way, from start to finish. 

So, Who do we Work with?

We’ve been creating MDA-certified and FDA-approved light therapy devices for years. That said, we’ve successfully worked with various brands in different industries, taking their ideas and bringing them to life. Here are some of the brands and products we’ve developed.

DemarkQ

DenmarkQ offers skin care devices that use red and blue light LED to target acne and scarring. The LED light uses the body's natural healing process to improve its overall wellbeing. 

Aduro Mask
Established in 2006, Aduro Skincare specializes in LED beauty-related products under a medical license. The product is internationally renowned and clinically proven as an effective, non-invasive therapeutic skin care treatment.

Perfect Countour

Perfect Contour is our line of permanent make-up machines. Our permanent make-up machines were designed for clinical use; however, we feel permanent make-up is more of an art form than a medical procedure through our experience.

Golden Eagles

Teeth whitening has been around for ages, and we've mastered the art of developing effective teeth whitening devices. We currently have over 20 different OEM models for professional whitening and devices for at-home whitening. 

Akstra

Akstra's brand focuses on hair regrowth and hair rejuvenation and offers products ranging from home-use to professional-use models. Since Asktra's first line of hair lasers was made for clinical environments, we opted for a sleek and clean design. 

Lumiceuticals

Lumiceuticals is a brand focusing on using LED technology for pain relief. We combined LED technology with neoprene material for practical treatment pads. The pads are secured by Velcro straps, making them easy-to-use for customers. 

If you’re considering developing private label light therapy devices, at Kaiyan Medical, we create MDA-certified and FDA-approved light therapy devices, ensuring you medical-grade, high-quality devices for your business. We are eager to work with like-minded partners in developing truly effective, safe, and valuable products that tap into the power of light therapy. 

We look forward to working with you!


Why Chiropractors Love Light Therapy

Why Chiropractors Love Light Therapy

Chiropractors Lead the Way

LED light therapy is not new to the medical industry and certainly not new to doctors of chiropractic.

Studied for decades, the use of low-level light therapy (LLLT) — both LED and laser — has been making its way into the medical mainstream in the U.S. since the 1990s. And chiropractors have taken the lead in the clinical use of LED light therapy and are advancing the use of this technology for new applications.

This is no surprise to industry professionals and medical providers because this technology is a perfect pairing to what chiropractors advocate and bring to the medical community: healthy, drug-free healing and pain management options that are highly efficacious. Compared to the high cost and side-effect spectrum of many pharmaceutical drugs, LED light therapy can be a cost-effective alternative to drugs and surgery.

LED light therapy has the ability to increase blood flow and lymphatic circulation, decrease pain, and stimulate many cellular processes that accelerate healing. Plus, it has a high safety level, no known negative side effects is easy to administer, and is non-invasive.

Because LED light therapy can provide pain relief, wound healing and address neuropathy discomfort and various musculoskeletal issues, it is a mainstay in many clinics. Some patients also purchase light therapy systems from their chiropractors for in-home use between office visits for long-term therapy needs such as chronic pain and neuropathy.

It is also an attractive option for new chiropractors just getting started because it can bring substantial benefits to their patients while offering a fast ROI.

How it Works

LEDs deliver wavelengths of incoherent (diffused) light to the body. LEDs are similar to laser diodes, but their light spreads out, unlike the highly focused beam of coherent light that emits from a laser. This more diffused light makes administration exceptionally safe.

This therapy is also known as photobiomodulation — meaning that light can produce a cellular change in the body. Photons of light stimulate the release of nitric oxide, which

is the body’s natural vasodilator, greatly increasing circulation in the local treatment area. Blood flow is increased to nerves and other tissues, improving tissue oxygenation that stimulates healing. This boost persists for several hours after a therapy session.

Research indicates that the benefits of LED light therapy include

  • Increased circulation
  • Decreased inflammation
  • Increased ATP production
  • Collagen production
  • Accelerated exercise recovery time
  • Increased relaxation
  • Decreased stress

LEDs have low power requirements and high efficiency with minimal heat production. Power levels are measured in mW/cm2 (milliwatts per centimeter squared). And LED lifetimes are rated up to 100,000 hours and can last for decades.

The most common device wavelengths are the following:

  • Near-infrared: Many LED therapy devices use the 800 nanometers (nm) range; however, infrared include a much wider spectrum with deep penetration up to 100 mm.
  • Red: 630 to 700 nm, with penetration up to 10 mm.
  • Blue: 405 to 470 nm, with penetration up to 3 mm (beneficial for skin and wound healing).
  • Pulsed frequency(s) or continuous wave devices provide timed sequences of light turning on and off during application, which is thought to accelerate change in the tissues.
  • Continuous-wave devices are always on; no frequency is added to the light.
Applications for Use

Light therapy is commonly used to treat acute and chronic joint pain in the neck, back, leg, shoulder, wrist, knee, and ankle. It can be helpful for arthritis pain, bruises, carpal tunnel syndrome, and musculoskeletal conditions. It is also used to treat skin conditions such as pressure ulcers, wound healing, and scar tissue reduction.

Even NASA has good things to say about light therapy. NASA issued a news release in December 2000, which stated that doctors at Navy Special Warfare Command centers in Norfolk, Virginia, and San Diego reported a 40 percent improvement in patients who had musculoskeletal training injuries treated with light-emitting diodes.1

There are distinct advantages to using LED therapy devices in your clinical practice. For example, Patients can be left unattended during therapy, maximizing staff resources. Large surface areas can be covered by the LED pad or panel, delivering therapeutic photons broadly and safely to the body's targeted area. And systems are generally portable and user friendly.

Moreover, LED light therapy can help you enter niche markets, such as peripheral neuropathy and brain injuries. These are areas where LED light therapy is appearing to be more effective than pharmaceutical approaches.

Brain injuries

An increasing number of scientific studies show expanded indications for LED light therapy to treat neurologic conditions, especially brain injuries and degeneration. The advanced research being done by Michael Hamblin, Ph.D., and his group and by Margaret A. Naeser, Ph.D., at Boston University demonstrates that LED light therapy can positively affect the brain. Naeser’s 2017 study with veterans showed significant improvement after 12 weeks of transcranial photobiomodulation.

Increased function, better sleep, fewer angry outbursts, and less anxiety and wandering were reported with no negative side effects.2

Preliminary brain studies conducted by other groups using transcranial LED light therapy show impressively improved brain blood flow verified before and after single-photon emission computerized tomography (SPECT) brain scans. These brain studies have implications for patients presenting with such conditions as traumatic brain injury (TBI), PTSD, Alzheimer’s, Parkinson’s, concussions, strokes, and depression.

Nearly all neurological disorders have one thing in common: diminished blood flow. And increased circulation and blood flow are precisely what LED light therapy promotes.

Peripheral Neuropathy

More than 3 million new cases of peripheral neuropathy are diagnosed each year in the U.S. alone. LED light therapy has shown significant results in relieving this condition's discomfort and improving sensation, as evidenced by several studies.

Adding LED light therapy systems can help you offer neuropathy therapy as a substantial part of your practice.

FDA Approved

LED light therapy devices have received FDA clearances that temporarily increase local circulation; and the temporary relief of pain, stiffness, and muscle spasms. Many practitioners are hopeful that the FDA will keep expanding clearances for this cutting-edge healing technology.

References
NASA/Marshall Space Flight Center. “NASA Space Technology Shines Light On Healing.” ScienceDaily. http://www.sciencedaily.com/ releases/2000/12/001219195848.htm. Published Dec. 2000. Accessed Jan. 2018.

Salmarche AE, Naeser MA, Ho KF, Hamblin MR, Lim L. Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation:

Case Series Report. Photomed Laser Surg. 2017;5(8):432–441.

Fallah A, Mirzaei A, Gutknecht N, Demneh AS. Clinical effectiveness of low-level

laser treatment on peripheral somatosen- sory neuropathy. Lasers Med Sci. 2017 Apr;32(3):721–728.

Mandelbaum-Livnat MM, Almog M, Nissan M, Loeb E, Shapira Y, Rochkind

Photobiomodulation Triple Treatment in Peripheral Nerve Injury: Nerve and Muscle Response. Photomed Laser Surg. 2016;34(12):638–645.



What Are the Different Types of Clinical Research?

What Are the Different Types of Clinical Research?

Different types of clinical research are used depending on what the researchers are studying. Below are descriptions of some different kinds of clinical research.

Treatment Research generally involves an intervention such as medication, psychotherapy, new devices, or new approaches to surgery or radiation therapy.

Prevention Research looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

Diagnostic Research refers to the practice of looking for better ways to identify a particular disorder or condition.

Screening Research aims to find the best ways to detect certain disorders or health conditions.

Quality of Life Research explores ways to improve comfort and the quality of life for individuals with a chronic illness.

Genetic studies aim to improve disorders' prediction by identifying and understanding how genes and illnesses may be related. Research in this area may explore how a person’s genes make him or her more or less likely to develop a disorder. This may lead to the development of tailor-made treatments based on a patient’s genetic make-up.

Epidemiological Studies seek to identify the patterns, causes, and control of disorders in groups of people.

An important note: some clinical research is “outpatient,” meaning that participants do not stay overnight at the hospital. Some are “impatient,” meaning that participants will need to stay for at least one night in the hospital or research center. Be sure to ask the researchers what their study requires.

Phases of Clinical Trials: When Clinical Research is Used to Evaluate Medications and Devices
Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as psychotherapy or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

  • Phase I trials
    Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.
  • Phase II trials
    The experimental drug or treatment is given to a larger group of people to see if it is effective and further evaluate its safety.
  • Phase III trials
    The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information to allow the experimental drug or treatment to be used safely.
  • Phase IV trials
    Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information, including the treatment or drug’s risks, benefits, and best use.

Examples of Other Kinds of Clinical Research
Many people believe that all clinical research involves testing new medications or devices. This is not true, however. Some studies do not involve testing medications, and a person’s regular medications may not need to be changed. Healthy volunteers are also needed so that researchers can compare their results to the results of people with the illness being studied. Some examples of other kinds of research include the following:

  • A long-term study that involves psychological tests or brain scans
  • A genetic study that involves blood tests but no changes in medication
  • A family history study involves talking to family members to learn about people’s medical needs and history.

Advantages of Medical Device Manufacturing in China Post Covid-19

Advantages of Medical Device Manufacturing in China Post Covid-19

China’s overall economic recovery in part has been attributed to the strong rebound in the manufacturing sector. The medical device manufacturing sector specifically recorded an astounding 46.4% growth.

High-Quality Human Resources

Despite living in the age of automation, labor remains one of the higher costs of manufacturing. Manufacturing companies in the west have to deal with worker’s unions, paying high wages, and inflexible staffing that cannot readily scale and resize as fluctuating production output needs may require. On the other hand, achieving this flexibility level is easier for Chinese manufacturers due to China’s readily available, efficient workforce. This used to be the primary reason for companies to outsource their manufacturing activities in China.

Manufacturing in China can significantly bring down overall production costs, and a large part of those savings is due to Chinese labor efficiency. Chinese facilities have been optimizing manufacturing costs for decades and have largely achieved very efficient workforce operations. Depending on the labor intensity of product manufacturing activities, a Chinese facility can offer an excellent number of parts produced per work hour spent.

Low Raw Materials Cost

Another most important manufacturing cost is raw materials cost, for which China also provides a cost-effective option, for two main reasons. Firstly, the same labor efficiency condition exists throughout the entire raw materials production value chain. So Chinese manufacturing companies can themselves access cost-efficient raw materials than most companies based in other countries. Secondly, the transfer of materials is cheap since it only happens from close sources and within China. This results in avoiding long shipping routes, additional customs tariffs, and long delivery waiting times. When manufacturers in all industries are trying to cut expenses and maximize profits to remain competitive, access to affordable raw materials can help bring down manufacturing costs to a considerable extent.

Most Chinese manufacturing facilities will typically have low cost local (or close) material suppliers. This way, they gain a significant cost advantage that further contributes to their cost-effectiveness.

Strategic Location

Companies worldwide are nowadays targeting the growing Asian markets, so much so that the phrase “expand to Asia” has become somewhat of a cliché business term. China is the largest of those markets, with its consumer market surpassing $6 trillion in value. Moreover, it also benefits from its proximity to several large and growing markets, such as India and South Korea. In terms of regulatory compliance, medical devices of Chinese manufacturing have no issues in being accepted in both the country’s domestic and other Asian markets. So outsourcing medical device production to China gives manufacturers access to its rapidly growing domestic market, as well as immediate access to its developing neighboring markets.

Evolving Supply Chain Network

In times of market, instability is when a supply chain is a huge determining factor for a manufacturer’s chance for survival. Chinese materials suppliers have been rapidly evolving, following the country's growing trend of becoming an international manufacturing hub. This has made it easier for medical device contract manufacturers to identify and establish a trustworthy network of reliable local suppliers.
This gives the more top tier Chinese manufacturers such as Kaiyan, the opportunity to create resilience in the face of the coronavirus outbreak. Additionally, a robust supply chain allows for a manufacturer’s flexibility to offer simple, efficient, and flexible options for increasing or scaling production as market needs change. What’s also important is that this supply chain evolution has also increased quality standards, which is a decisive factor in medical device manufacturing.

Access to Cutting-edge Technology

Realizing the potential of its market in the era of globalization, China has spent the last decades developing its technology. Heavy investments in research and development, importing talent and technology, and the emergence of specialized tech hubs have helped China gain an innovation edge over other emerging countries. The mentality of rapid research and development is of notable importance and surpasses the speed of many tech hubs in the west. Part of the reason this happens is that such a large portion of the world’s product manufacturing has been outsourced to China. And the low costs achieved by Chinese companies are not the result of just cheap labor, but also, to an extent, involve practical applications of innovative technologies.

Flexible Scale of Manufacturing

Another benefit of manufacturing in China is the ability to scale up or down as needs change. Top tier Chinese factories such as Kaiyan’s facilities are manufacturing products for many companies at the same facility, so they have the means to produce large quantities and adapt according to the market’s and customer’s needs. And being able to scale up easily is an obvious advantage. A critical characteristic of every trade is offering product availability. As you market your medical device to new markets, customers, importers, and distributors, you will be required to increase quantities and ensure timely delivery. Manufacturing your medical device in a Chinese facility that can support scaling up production becomes an obvious advantage.

Clinical Trials for Medical Devices: FDA and the IDE Process

Clinical Trials for Medical Devices: FDA and the IDE Process

What is a Medical Device?

Section 201(h) of the Food, Drugs, and Cosmetics Act defines a medical device as any healthcare product that does not achieve its principal intended purposes by chemical action or metabolized.

Medical Device Classes
  • Class I — General Controls — Most exempt from premarket submission.
  • Class II — Special Controls — Premarket Notification [510(k)].
  • Class III — Premarket Approval — Require Premarket Application [PMA].
510(k) Premarket Notification
  • Substantial equivalence.
  • 10–15% require clinical data.
  • Performance testing.
  • Usually confirmatory.
  • Type of study dictated by
  • The ability of bench and animal testing to answer questions.
  • Amount of difference between subject device and predicate.
PMA Premarket Approval Application
  • Establish reasonable assurance of safety and effectiveness.
  • Bench-Animal-Human.
  • Clinical Studies.
  • Feasibility and pivotal.
Stages of Review for PMA Device
  1. Pre-Sub: Discuss the device design, bench/animal testing, and the clinical trial
  2. IDE: Request approval for a clinical trial.
  3. PMA: Request market approval.
  4. PMA-S: Request approval for device change or upgrade.

What is an Investigational Device Exemption (IDE)?

The FDA approval of an IDE is required for US human study of a significant risk device that is not approved for the study's indication.

Device trials are unique.

  • Trials tend to be smaller than drug trials.
  • Some novel, many “me-too.”
  • Many difficult to blind, randomize, and control.
  • Many depend on physician technique.
  • Device modifications occur during the trial.
  • Endpoints are highly diverse.
  • Typically, a single pivotal trial follows the feasibility stage(s).
  • Designed to support a “reasonable assurance of safety and effectiveness” for the marketing application.

Types of IDEs

Feasibility Study
  • May provide support for a future pivotal study or may be used to answer basic research questions.
  • Not intended to be the primary support for a marketing application.
  • Endpoints and sample size are generally not statistically driven.
  • Often required by the FDA before the pivotal study to assess basic safety and potential for effectiveness.
  • Generally ~10–40 patients but may be larger.
  • The FDA review is primarily focused on safety and whether the data's potential benefit or value justifies the risk.
Pivotal Study
  • Designed to demonstrate a “reasonable assurance of safety and effectiveness. ness.”
  • Generally intended as the primary clinical support for a marketing application.
  • Endpoints and sample size are statistically driven.
  • Designed to assess both safety and effectiveness.
  • FDA review is much more complex.

Basic Submission Elements

Background of medical issue, the study goals, and why this study will further the science.

A Detailed Description of the Device Understudy
  • Previous studies (preclinical and clinical).
  • Summary of available data.
  • Why is a clinical study needed at this stage?
  • What evidence supports this study/device's safety and the study data's potential to be meaningful?
  • Are there outstanding safety questions that should be addressed with preclinical data?
Risk analysis

Should include:

  • What are the potential risks to the patient?
  • Does the study mitigate the risks where possible?
  • Are the risks outweighed by the potential for benefit and/or value of the study?
  • Patient monitoring and follow-up plan.
  • Inclusion and exclusion criteria.
  • Informed consent document.
  • Sample size and the number of investigational centers, with justification.

Submission Elements, Pivotal IDEs

Primary and Secondary Endpoints

Discussion of the appropriateness of endpoint parameters, hypotheses, and success criteria

Basic Trial Design
  • Controlled? If not, why not?
  •   Randomized? If not, why not?
  •   Blinded? If not, why not?
Trial Conduct and Study Monitoring
  • Sponsor blinding
  • Data handling and adjudication process
  • Independent committees
  • Case report forms
  • Is the right information being gathered to support the study endpoints, and are investigators adequately prompted to report adverse events?

Primary Endpoint Design

Should evaluate the safety and effectiveness of the device in the population expected to be indicated.

  • Generally divided into 1 or more “safety” endpoints and 1 or more “effectiveness” endpoints.
  • A study will be considered successful if both the safety and effectiveness endpoints are met.
  • The clinical protocol should clearly and prospectively detail: — Methods for obtaining endpoint data — Definitions for what will be counted as a primary event in the analysis — Situations in which patient data will be excluded — How missing data will be handled — How the impact of covariates will be assessed.

Sample Size & Follow-Up

Driven by either:

  • Primary safety endpoint
  • Primary effectiveness endpoint

The minimum number of patients and/or minimum duration of follow-up may be required depending on:

  • Understanding of the device's safety and effectiveness  
  • concerns regarding the durability of device safety or effectiveness.

Secondary Endpoints

Generally used to evaluate additional meaningful claims.

  • Generally only considered if primary endpoints are successful.
  • It should be used to provide further insight into the device's effects and mechanisms of action.
  • Definitions and analysis methods should be clearly detailed prospectively.
  • Not considered “statistically significant” unless a pre-specified alpha allocation plan is in the protocol, even if the p-value is < 0.05.

FDA’s IDE Review Decisions

  1. Approval — Approves the trial for a specified number of patients and investigational centers.
  2. Approval with Conditions — Allows sponsor to begin the trial if the sponsor agrees to address the conditions (deficiencies) from the conditional approval letter within 45 days.
  3. Disapproval — The trial may not start until the sponsor addresses the letter's deficiencies, submits this information to the FDA, and receives approval.

Conclusions

One size does not fit all for device trials. Pivotal studies should be designed to evaluate whether there is a “reasonable assurance of safety and effectiveness.” PMA approbation is based upon a Benefit-Risk assessment that strongly considers the outcome of primary safety and effectiveness endpoints. Secondary endpoints are generally used to support claims if the primary endpoints are successful. All endpoint analyses and definitions should be clearly pre-specified in the approved clinical protocol.

Sinus Infections & Low-level Laser Therapy

Sinus Infections & Low-level Laser Therapy

Sinus infections are inflammation based. Sinusitis is when inflammation is chronic, and the body is unable to overcome it. Sinusitis or sinus infections may be acute (coming on suddenly) or chronic (long-lasting & nothing seems to fix it.

There are sinus cavities above the eyebrows, behind the nose, and under the cheekbones. When the mucus membranes within the sinuses become inflamed, mucus is generated. Sometimes even air is trapped, which puts pressure on the walls of the sinus cavities, making our face hurt, causing difficulty in breathing thru the nose — this is called sinusitis.

Studies have shown that 37 million people per year in the US are affected with sinusitis at one time or another involving all age brackets.

Is There a Natural, Safer Treatment Option?

Some people immediately run to a doctor wanting antibiotics, which may not help since not all sinusitis is due to bacteria. Low-level laser therapy (LLLT) has been proven effective in enabling the body to overcome inflammation. Many of our patients find that when they use low light Laser Therapy to treat their sinus infections, they experience two things: First — patients notice a significant difference after 1 treatment (breathing easier and sinus drainage); Second — they are less likely to get recurring infections, as is often the case when taking antibiotics.

Irradiation of red light penetrates several millimeters into tissue; in the infrared part of the spectrum, the penetration goes up to several centimeters, usually 4–6 cm. This is a very advantageous fact for treating sinusitis, for laser irradiation can be applied externally. However, when applying a red laser, it is necessary to introduce a light guide in the sinus.

Laser therapy is a safe, painless, non-invasive, and effective therapy to reduce pain and swelling, allowing the body to restore damaged tissue. Laser therapy uses red and infrared light to relieve pain and accelerate healing and decrease inflammation. When the light source is placed against the skin, the photons penetrate several centimeters and get absorbed by the mitochondria, the cell’s energy-producing cells part. This energy fuels many positive physiological responses resulting in the restoration of normal cell function. Laser therapy offers our bodies the opportunity to heal with no side effects and no long term damage.

Long Term/Cumulative Effects of Laser Therapy:

  • Improved resistance to infections
  • The immune response is stimulated
  • Reduction in swelling
  • Lymphatic drainage is improved
  • The body’s natural healing process is enhanced

LLLT irradiation is a benefit for the treatment of acute sinusitis. External irradiation with a laser with 830 nm wavelength, enabling the beam to penetrate 4–6 cm deep, is recommended. Irradiation with red light-emitting lasers is also effective. Still, due to the need for application through a light guide inserted into the cavity, this method has been discarded from clinical practice.

Laser irradiation works through its analgesic, anti-inflammatory, and biostimulation effects on ease of pain or elimination. It also causes a quicker withdrawal of inflammation and edema of the mucosa. It thus brings restoration of drainage of sines as well as normalization of mucociliary function. Immunomodulatory effect — improvement of both specific and non-specific immunities by stimulation of T and B lymphocytes, lysozyme, and phagocytosis — is also significant. Stimulation of Langerhans cells of the mucose of sines is presumed, too.

Laser irradiation in treating sinusitis has no contraindications (except for general contraindications, i.e., malignant tumors in the irradiation area or epilepsy). As physiotherapy, it can suitably complement therapy with antibiotics, mucolytics, and antihistaminics. The use of a laser with 830 nm wavelength appears to be the most beneficiary on diagnosis sinusitis acute with liquid levels in paranasal sinuses, the treatment of which was cut down by 59 percent in average, and on a group of patients with plain catarrhal obscure and decreased transparency (the most frequent) where the duration of therapy was shortened by 39 percent.

By using red light therapy devices from Kaiyan Medical, you’re able to reduce sinus inflammation and improve your immune system by investing a few minutes using a red light device.

With Autoimmunity on the Rise, Light Therapy is Here to Aid in Prevention and Treatment

With Autoimmunity on the Rise, Light Therapy is Here to Aid in Prevention and Treatment

The medical industry has taken great strides in helping to improve our understanding of the human body. We’ve found an effective treatment for Hepatitis C, eradicated smallpox and rinderpest, and are working on treatments to cure cancer. No one can say we haven’t been successful in the medical world, particularly with the help of incredible research and technology. 

However, there is one family of disease that continues to be somewhat of a mystery in the medical world. And while it’s being highly studied, more and more people are being diagnosed with it. 

What’s the mystery disease? It’s autoimmunity. 

Now, autoimmune diseases can vary greatly, as it's an umbrella term for many autoimmune-based disorders. However, they all have one common thread, in that the body's natural defense system cannot tell the difference between your own cells and foreign cells. This causes the body to attack its own cells healthy unknowingly. 

Under the term "autoimmune diseases," there are around 80 different types that affect various parts of the body, with some of the most common forms manifesting as celiac, IBS, multiple sclerosis, and rheumatoid arthritis.  

The symptoms of autoimmune diseases aren’t pleasant ones by any means. However, they do range depending on the specific condition. Many people with an autoimmune disease experience multiple symptoms such as severe inflammation, joint and pain swelling; as well as skin conditions, recurring fever, swollen glands, and digestive issues. 

Though we know the symptoms of autoimmune diseases, the underlying cause can be difficult to determine for patients – exact cause of autoimmune disorders is unknown. 

More importantly, autoimmune disorder cases are rising. A study published this year showed a staggering rise in autoimmunity in the U.S., particularly in the rate of people testing positive for antinuclear antibodies (ANA), the most common marker of autoimmunity. Over the course of 25 years, the researchers found an overall 50 percent increase. That is astounding. 

Even though we understand these diseases are increasing, we don't know why.

But there is more and more evidence that the balance of microbiome in our guts plays a significant role. Having a diverse range of microbes positively influences our immune systems. People living in developed countries have higher rates of autoimmune diseases due to our less microbially environments. In other words, we're inside more, overuse antibiotics, live with chronic stress, and have poor diets. Not a great combination for a long and healthy life. 

Autoimmune disorders are a reflection of the unhealthy environment we've created for ourselves. We're overworked, stressed, and not supplying our bodies with the proper nutrients. Of course, a lifestyle change is necessary to reduce autoimmune disorders cases and symptoms. But there's another thing you can do to help yourself, and that's by undergoing at-home light therapy treatment

First, light therapy helps to improve immune cells, which is crucial for those with autoimmune disorders. When undergoing red light therapy, cells respond to the wavelengths. Pro-inflammatory cytokine TNF-α is released from the cells, and leukocytes (white blood cells) can enter the body's tissue to promote healing. In addition, red light therapy aids in activating lymphocytes, which increases the movement of epithelial cells, thus healing wounded areas quickly and increasing cell turnover rates. 

But there are other symptoms red light therapy focuses on, and it's joint pain and inflammation. For people who have rheumatoid arthritis, fibromyalgia, and other autoimmune diseases, inflammation and pain are a daily struggle. One study found that light therapy significantly improved inflammatory cells during both the early and late stages of Rheumatoid arthritis. 

By using Lunas’ red light therapy devices, you’re able to tackle multiple symptoms of autoimmune disease, reduce your stress levels, and improve your immune system by investing a few minutes sitting or standing in front of your red light device.

PEMF Therapy in the Treatment of Osteoporosis and Similar Conditions

PEMF Therapy in the Treatment of Osteoporosis and Similar Conditions

Osteoporosis is a systemic skeletal disease, characterized by the reduction of bone mass and the skeletal architecture's impairment as a whole. Theron is essentially disease's definitions on anatomopathological criteria, which attribute to the skeleton particular characteristics of fragility, such as making bone prone to fracture even after minor trauma.

Skeletal fragility can be diagnosed, thanks to current sensitometric methods, even in the absence of symptoms and fractures. Being a condition that heightens the risk of fracture, but that does not make itself necessary for the definition of the disease, osteoporosis can evolve in a completely asymptomatic way for a long time, in some cases even for a lifetime.

The US FDA has approved pulsed electromagnetic fields (PEMFs) as a safe and effective treatment for nonunion of bone. Despite its clinical use, the mechanisms of action of electromagnetic stimulation of the skeleton have been elusive. Recently, cell membrane receptors have been identified as the site of action of PEMF and provide a mechanistic rationale for clinical use. This review highlights key processes in cell responses to PEMF as follows: (1) signal transduction through A2A and A3 adenosine cell membrane receptors and (2) dose-response effects on the synthesis of structural and signaling extracellular matrix (ECM) components. Through these actions, PEMF can increase bone and cartilage's structural integrityECM's structural integrity, enhance enhance repair, and alter the homeostatic balance of signaling cytokines, producing anti-inflammatory effects. PEMFs exert a pro anabolic effect on the bone and cartilage matrix and a chondroprotective effect counteracting inflammation's catabolic effects in the joint environment. Understanding of PEMF membrane targets and the specific intracellular pathways involved, culminating in the synthesis of ECM proteins and reducing inflammatory cytokines, should enhance confidence in the clinical use of PEMF and identify clinical conditions likely to be affected by PEMF exposure.

The musculoskeletal system is highly responsive to its physicochemical environment. Bone and cartilage cells respond to changes in mechanical stress, fluid flow, pH, and pO2 by altering their phenotype and expressing a range of signaling and structural molecules that result, in particular, in an altered extracellular matrix (ECM) organization and associated biomechanical properties. Response to mechanical stress is perhaps the best recognized and intuitively obvious skeletal environmental condition, facilitating adaptation and modeling to changing biomechanical and environmental requirements, perhaps through intermediary strain-associated signaling events. In addition to mechanical stress, skeletal tissues, both bone, and cartilage, demonstrate an exquisite sensitivity to electrical and electromagnetic stimulation.

Responses of skeletal cells to pulsed electromagnetic fields (PEMF) have been exploited therapeutically with devices that expose tissues to appropriately configured fields to stimulate ECM synthesis for bone and cartilage repair. This review highlights key processes in cell responses to PEMF as follows: (1) signal transduction through cell membrane adenosine receptors (ARs), (2) the activation of osteoinductive pathways, and (3) the synthesis of skeletal ECM including structural and signaling molecules. These actions are reflected physiologically in the bone as the healing of fractures, osteotomies, nonunions, and joints, as the modulation of cartilage damage and reduction in catabolic and inflammatory cytokines in arthritis. Understanding the cellular responses to PEMF will inform clinical studies, may point to key issues that need further investigation, and will be relevant in promoting bone and cartilage repair, tissue engineering and regeneration in a repair mode, and damping inflammation in arthritis. Understanding the pathways of the activity of PEMFs provides a solid mechanistic basis for their clinical use.

There is strong evidence supporting a role for adenosine and its receptors in bone homeostasis and skeletal pathology, including osteoporosis and arthritis.4 Furthermore, adenosine, acting through the A2A receptor, inhibits osteoclast differentiation, and increases the rate of new bone formation in bone defects.5 A2A signaling also promotes the Wnt/β-catenin pathway regulating bone formation.6

Although the transmembrane signal recognition processes of PEMF are incompletely understood, the specific mechanism of interaction between PEMF and the cell membrane was reported by Varani et al.7 They identified for the first time that ARs were the main target of PEMF stimulation in inflammatory cells; ARs play a pivotal role in the regulation of inflammatory processes, with both pro-inflammatory and anti-inflammatory effects.8 It has been demonstrated that PEMF exposure induces a notable increase in A2A and A3 AR density on the cell membrane of chondrocytes, synoviocytes, and osteoblasts8 (Figure 1). Notably, A1 and A2B receptors were not influenced by the same exposure conditions. Moreover, in the presence of the specific A2A receptor agonist, PEMF exposure synergized with the agonist and induced a notable increase in intracellular cyclic adenosine monophosphate (cAMP) levels. On the contrary, the specific A2A receptor antagonist's presence blocked the effects of both the agonist and PEMF stimulation, suggesting that PEMFs specifically act through the activation of A2A ARs with a pharmacologic-like mechanism. The agonist activity of PEMF for the A2A and the A3 ARs is particularly relevant because it inhibits the NF-kB pathway, a key regulator of the expression of matrix metalloproteinases and several genes involved in responses to inflammation.9 Cohen et al. 10 showed in vivo that an experimental A2A agonist drug reduced cartilage damage in a rabbit model of septic arthritis of the knee. These observations formed the basis for the application of PEMF for chondroprotection of articular cartilage from the catabolic effects of joint inflammation, as discussed in more detail later.

Despite its clinical use, the mechanisms of action of electromagnetic stimulation of the skeleton have been elusive, and PEMF has been viewed as a “black box.” In the past 25 years, research has successfully identified cell membrane receptors and osteoinductive pathways as sites of action of PEMF and provides a mechanistic rationale for clinical use. Understanding of PEMF membrane targets and the specific intracellular and extracellular pathways involved, culminating in the synthesis of ECM proteins and reduction in inflammatory cytokines, should enhance confidence in the clinical use of PEMF and the identification of clinical conditions likely to be affected by PEMF exposure.

The biological effects of PEMF treatment and favorable effects on the skeletal system are the results of notable research efforts conducted internationally by the orthopedic community. They have attracted much interest from other medical specialties such as wound and tendon healing, rheumatology, and neurology that may be able to take advantage of the experiences developed with bone and cartilage treatments.

References

De Mattei M, Fini M, Setti S, et al.: Proteoglycan synthesis in bovine articular cartilage explants exposed to different low-frequency low-energy pulsed electromagnetic fields. Osteoarthritis Cartilage 2007;15:163–168.

Parent D, Franco-Obregon A, Frohlich J, et al.: Enhancement of mesenchymal stem cell chondrogenesis with short-term low intensity pulsed electromagnetic fields. Sci Rep 2017;7:9421.

Aaron RK, Ciombor DM, Keeping H, Wang S, Capuano A, Polk C: Power frequency fields promote cell differentiation coincident with an increase in transforming growth factor-beta(1) expression. Bioelectromagnetics 1999;20:453–458.

Ham J, Evans BA: An emerging role for adenosine and its receptors in bone homeostasis. Front Endocrinol (Lausanne) 2012;3:113.

Mediero A, Wilder T, Cronstein B: Adenosine receptors stimulate bone regeneration, in Biology and Pathology of Bone and Joint: Osteoclasts, Osteoblasts and Bone Remodeling. Boston, MA, ACR/ARP Annual Meeting, 2014, Abstract 19.

Borhani S, Corciulo C, Larranaga Vera A, Cronstein B: Signaling at adenosine A2A receptor (A2aR) in osteoblasts; crosstalk with Wnt/β-catenin signaling pathway, in Osteoarthritis and Joint Biology — Basic Science Poster I. Chicago, IL, ACR/ARP Annual Meeting, 2018, Abstract 1047.

Varani K, Gessi S, Merighi S, et al.: Effect of low-frequency electromagnetic fields on A2A adenosine receptors in human neutrophils. Br J Pharmacol 2002;136:57–66.

Varani K, Vincenzi F, Ravani A, et al.: Adenosine receptors as a biological pathway for the anti-inflammatory and beneficial effects of low-frequency low energy pulsed electromagnetic fields. Mediators Inflamm 2017;2017:2740963.

Massari L, Benazzo F, Falez F, et al.: Biophysical stimulation of bone and cartilage: State of the art and future perspectives. Int Orthop, 2019;43:539–551.

Cohen SB, Gill SS, Baer GS, Leo BM, Scheld WM, Diduch DR: Reducing joint destruction due to septic arthrosis using an adenosine2A receptor agonist. J Orthop Res 2004;22:427–435.

Aaron RK, Boyan B, Ciombor DM, Schwartz Z, Simon BJ: Stimulation of growth factor by electric and electromagnetic fields. Clin Orthop Rel Res 2004;419:30–37.

Aaron RK, Wang S, Ciombor DM: Upregulation of basal TGFß1 levels by EMF coincident with chondrogenesis — skeletal repair and tissue engineering implications. J Orthop Res 2002;20:233–240.

13. Zhou J, He H, Yang L, et al.: Effects of pulsed electromagnetic fields on bone mass and Wnt/beta-catenin signaling pathway in ovariectomized rats. Arch Med Res 2012;43:274–282.

Lin CC, Lin RW, Chang CW, Wang GJ, Lai KA: Single-pulsed electromagnetic field therapy increases osteogenic differentiation through Wnt signaling pathway and sclerostin downregulation. Bioelectromagnetics 2015;36:494–505.

Cai J, Shao X, Yang Q, et al.: Pulsed electromagnetic fields modify the adverse effects of glucocorticoids on bone architecture, bone strength, and porous implant osseointegration rescuing bone-anabolic actions. Bone 2020;133:115266.

Zhai M, Jing D, Tong S, et al.: Pulsed electromagnetic fields promote in vitro osteoblastogenesis through a Wnt/beta-catenin signaling-associated mechanism. Bioelectromagnetics 2016;37:152–162.

Jing D, Li F, Jiang M, et al.: Pulsed electromagnetic fields improve bone microstructure and strength in ovariectomized rats through a Wnt/Lrp5/beta-catenin signaling-associated mechanism. PLoS One 2013;8:e79377.

Wu S, Yu Q, Lai A, Tian J: Pulsed electromagnetic field induces Ca(2+)-dependent osteoblastogenesis in C3H10T1/2 mesenchymal cells through the Wnt-Ca(2+)/Wnt-beta-catenin signaling pathway. Biochem Biophys Res Commun 2018;503:715–721.

Pan Y, Dong Y, Hou W, et al.: Effects of PEMF on microcirculation and angiogenesis in a model of acute hindlimb ischemia in diabetic rats. Bioelectromagnetics 2013;34:180–188.

Tepper OM, Callaghan MJ, Chang EI, et al.: Electromagnetic fields increase in vitro and in vivo angiogenesis through endothelial release of FGF-2. FASEB J 2004;18:1231–1233.

Hopper RA, VerHalen JP, Tepper O, et al.: Osteoblasts stimulated with pulsed electromagnetic fields increase HUVEC proliferation via a VEGF-A independent mechanism. Bioelectromagnetics 2009;30:189–197.

Goto T, Fujioka M, Ishida M, Kuribayashi M, Ueshima K, Kubo T: Noninvasive up-regulation of angiopoietin-2 fibroblast growth factor-2 in bone marrow by pulsed electromagnetic field therapy. J Orthop Sci 2010;15:661–665.

Petecchia L, Sbrana F, Utzeri R, et al.: Electro-magnetic field promotes osteogenic differentiation of BM-hMSCs through a selective action on Ca(2+)-related mechanisms. Sci Rep 2015;5:13856.

Pro Athletes Harnessing the Power of Red Light

Pro Athletes Harnessing the Power of Red Light

Originally from https://www.lunaspanel.com/post/pro-athletes-harnessing-the-power-of-red-light


Being a professional athlete is no joke, and when your body is a central part of your job, it needs to be very well taken care of. And even when athletes are doing all the right things to take care of their body, injuries are still widespread in professional sports; but it used to be that their career was over if an athlete was injured. But now, athletes can undergo surgery and pop back up on the court or field months later. How is that possible?

As most athletes know, a large portion of time is dedicated to repairing muscles and alleviating inflammation for the next game. Regardless of the sport, teams spend millions of dollars on professional physical therapists to guarantee their athletes receive the highest physical treatment standard.

The recovery process for an athlete is essential and a determining factor of how well they’ll perform during their careers. You’ll often hear the words “optimizing performance” when discussing the recovery process for athletes. Today, the recovery process isn’t just to heal an athlete but to naturally enhance their performance.

So, how do professional therapists optimize professional athletes’ performance and recovery? Well, red light therapy is turning out to be one of the most effective treatments for these high-performing individuals.

Professional trainers are always looking for natural ways to enhance their player’s performance. With light has proven to be a lead modality, many trainers and athletes use light therapy to enhance the body’s natural healing process. But how does it work?

When used, natural red light penetrates the skin and cells. When the light reaches the mitochondria, it stimulates the production of adenosine triphosphate (ATP). ATP is a natural energy currency in the human body. With an enhanced ATP production, cells in the muscle are optimized and repaired faster.

Hundreds of peer-reviewed clinical trials have backed up the results athletes see on the courts and fields. In 2015, researchers conducted a meta-analysis of placebo-controlled trials, and the results were astounding. They found that most clinical trials showed “significant improvement for the main measures related to performance,” including endurance and speed. And through this meta-analysis, it was concluded that “phototherapy (with lasers and LEDs) improves muscular performance and accelerates recovery when applied before exercise.”

However, red light therapy does more than recover muscle tissue. It also increases muscle strength, ultimately improving physical performance.

A 2016 study researched red light therapy on elite athletes and trained and untrained athletes. What was found was that red light therapy after training could increase muscle mass. So, not only does red light therapy accelerate the recovery process, but it also improves muscle strength.

But what about endurance? Being strong is only one aspect of being an athlete. Endurance is crucial when competing against an opponent. A triple-blind, placebo-controlled trial published in 2018 studied the effects of red light therapy on men and women undergoing endurance training on treadmills. It was found that red light therapy pre-exercise can “increase the time-to-exhaustion and oxygen uptake and also decrease the body fat in healthy volunteers when compared to placebo.”

Another study from 2018 completed by Brazilian researchers found that after their randomized, triple-blind, placebo-controlled trial on pro soccer players, those who underwent red light therapy stayed longer on the playing field. It was concluded that light therapy “…had a significant improvement in all the biochemical markers evaluated…pre-exercise [light] therapy can enhance performance and accelerate recovery…”.

Peer-reviewed clinical trials worldwide have all concluded the same thing: red light therapy works for increasing athletic performance levels. Luna’s red light therapy device can help professional athletes and the rest of us exercise regularly, recover from injuries, and improve our physical and muscular health.

The Frozen Healer - Cryotherapy

The Frozen Healer - Cryotherapy

Cryotherapy is a trend with a cult following in the recovery, wellness, and beauty industries. It can be used in combination with light therapy for better results. You may have heard people talking about it or seen celebrities or athletes posting themselves coming out of icy cold chambers on social media, but what is Cryotherapy? Why is everyone talking about it?

In its most basic form, Cryotherapy is simply the use of cold temperatures to heal the body. Using the cold to help our bodies recover from injury, inflammation, soreness, or relaxation has been used since the beginning. Putting ice on a wound or bruise, jumping in a cold lake, or taking an ice bath are basic cryotherapy forms. These methods cause stagnant blood to start moving again, promoting new blood flow, which brings healing. It is a fundamental, well-understood principle that has been widely accepted and used as a means of after the fact recovery but can be quite uncomfortable, inconvenient, and extremely inefficient compared to modern-day cryotherapy through the use of cryotherapy chambers.

Day by day

Modern-day cryotherapy lends from past cold modalities to provide a much more comfortable, convenient, and effective recovery through cryotherapy chambers. Cryotherapy chambers provide a quick, 2–3 minute private session of whole-body exposure to shallow temperatures in a dry, contained, breathable air environment. Add in some music, light therapy, and awesome fog from the cold, and it becomes a fun experience that completely distracts from how cold you just got!

The goal of true whole body cryotherapy is to expose as much skin as possible to temperatures of -166F or below for a short period of time (2–3 minutes) to create a drop in the external skin temperature of 30–40 degrees. The best way to measure this is to use an infrared temperature device before and after the session on the upper arm's back, measuring the two temperature readings' delta.

Effects of Cryotherapy

Blood rushing to the core is our body’s natural way of protecting our core organs from extreme cold. When exposed to freezing temperatures, blood rushes from our extremities to our core, creating a systemic response throughout the body that produces many benefits. Cold promotes increased blood flow, bringing fresh, oxygenated blood full of white blood cells to the body's areas that need it. Cryotherapy amplifies these positive effects and adds many more incredible benefits by activating the vagus nerve and causing vasoconstriction and vasodilation. The vagus nerve is responsible for the regulation of internal organ functions [NCBI]. The vagus nerve is activated by cold on the back of the neck and touches every major organ in the body.

Whole Body Cryotherapy is not just for extreme athletes or those with present injuries, either. The best practice is for healthy, normal adults (minors with doctors) to regularly practice whole body cryotherapy 3–5 times per week. It is important to maintain a constant cryotherapy regimen and not just use it when you feel you need it or are injured. It is a continual recovery modality that helps the body stay healthy and even resist injuries and illness.

The Bright Hope for Allergic Rhinitis

The Bright Hope for Allergic Rhinitis

As the name suggests, Allergic rhinitis (also known as hay fever) is an inflammatory disorder of the nasal mucosa, which occurs when the immune system overreacts to allergens in the air. This might sound small, but it affects 20% of the adult population and up to 40% of children.

Allergic rhinitis is biologically associated and equated with decreased learning, performance, productivity at work and school, and reduced life quality. It affects the quality of life, including fatigue, irritability, memory deficits, and depression. It is reflecting the social-economic costs and the negative impact on the quality of life.

Light Therapy for Rhinitis

If we talk about the current therapeutic options like allergen avoidance, medication, and immunotherapy, they are quite far from ideal. Light therapy has been treating immune-mediated dermatological conditions, e.g., psoriasis and atopic dermatitis.

Light Therapy has been There!

It is one of the oldest treatments that has been practiced in ancient times. Red light therapy has profound immunosuppressive effects on the human body.

As per ARIA guidelines, Red light therapy has been recommended for patients with allergic rhinitis who do not respond to standard medical treatment.

Now, the questions arise what the benefits of red light therapy are? Why should you opt for it?

Well, there are many benefits to using red light therapy:

  • Better and increased blood circulation in the nasal tissues
  • Enhanced local blood oxygen saturation
  • Reduced nasal obstruction (congestion) caused by nasal swelling
  • Improved nasal anti-virus ability
  • Repaired local blood capillaries
  • Strengthened detoxification ability of the nasal mucosa
The Mechanism

Light therapy treatment delivers light to pathological areas to promote tissue regeneration, reduce inflammation, and relieve pain. This treatment improves the nasal obstruction caused by Allergic rhinitis. The sessions involve illuminating the nasal cavity through specific wavelength log light ((660nm — 810nm) to the nose for a certain amount of time.

Most light therapy devices include one or two small LED light-emitting probes, which quickly stimulate the nasal cavity's blood capillaries.

Light therapy mechanisms reduce the number and function of dendritic cells and induce immunomodulatory cytokines like IL-10. Cytokines are a large group of proteins, peptides secreted by specific cells of our immune system. The Red Light therapy generates little heat, modulating mucosal blood supply and histamine release (organic nitrogenous compound involved in local immune responses). This heat alters mucosal blood supply.

The therapy shows improvement in the symptoms of nasal congestion and a decrease in nasal resistance. Studies showed that Phototherapy resulted in a significant improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Red light therapy resulted in a remarkable improvement of clinical symptoms for nasal itching, rhinorrhea, sneezing, and total nasal score.

Adopt light therapy and give your life a better quality. Improve the shape of your life; let the negativity and obstructions be at bay!

References:

Half a Trillion-Dollar Market  —  Men.

Half a Trillion-Dollar Market  —  Men.

There’s an emerging disruptor in the beauty industry as companies target a different consumer type to expand the half a trillion-dollar market — men.

Across the globe, men’s adoption of beauty use is already starting to take off. But the trend comes in many different shapes and forms. For beauty companies struggling to find new avenues of growth, it’s a huge opportunity to see whether men are looking for traditional grooming products, discreet moisturizers, beauty balms, or popular light therapy.

According to Allied Market Research, the men’s personal care industry is predicted to hit $166 billion by 2022. According to market researcher NPD Group, just last year, men’s skin-care products alone saw a more than 7% jump in sales and with the category currently valued at $122 million.

“In recent years, the notion that men can’t or shouldn’t be using skin-care products or caring more in general about all aspects of their appearance has been receding,”

Said Andrew Stablein, a research analyst at Euromonitor International, in a research note.

The success of digitally native brands catered directly to men such as Harry’s and popular subscription service Dollar Shave Club reveal

“the average men’s grooming routine isn’t about just shaving, but can be aided by using skin-care products,”

Stablein said.

Even high-end designers like Chanel have jumped on the trend, launching its first made-for-men skincare and cosmetics line known as “Boy De Chanel” last September.

“It seems that mass players are trying to expand their market and gain share in a slowing market by growing their user base,”

Said Alison Gaither, beauty and personal care analyst at Mintel.

This includes tutorials from U.K. makeup artist Charlotte Tilbury and Rihanna’s Fenty brand, which have both put out instructions for guys who want to use makeup subtly for a more groomed appearance.

According to Coresight Research, the Asia Pacific market is now one of the fastest-growing regions for men’s grooming and cosmetic product use. Jason Chen, general manager for Chinese online retail site Tmall, told Coresight that “supply cannot meet the demand for male make-up products across China.”

However, recent data suggests the new generation of beauty consumers prefer a non-binary approach altogether. According to NPD’s iGen Beauty Consumer report, nearly 40% of adults aged 18–22 have shown interest in gender-neutral beauty products and holistic products.

“There are so many … [people] growing up with the idea that you’re not tied to the gender you’re born with,”

Said Larissa Jensen, a beauty industry analyst at NPD.

“Beauty is no longer what you’re putting out as ‘ideal beauty.’ Beauty can be anything, anyone, and any gender.”

In 2016, shortly after Coty acquired CoverGirl, the brand made history with its first-ever “CoverBoy” featuring popular YouTube makeup artist James Charles.

Charles recently found himself in a very public spat with Tati Westbrook, another YouTube beauty vlogger. Coverage of the feud, which began after Charles backed a vitamin brand that was a rival to Westbrook’s own, has been widespread and shows the influence these internet personalities have and how the business has evolved over the past two years.

While Charles may be having his struggles now, as he has lost millions of subscribers, the attention he originally received from CoverGirl sparked similar collaborations by major brands including L’Oreal, who featured beauty blogger Manny Gutierrez, known under the moniker Manny MUA, as the face of its Maybelline Colossal mascara campaign in 2017.

“I think a lot of people misconstrue a man wearing makeup as someone that is transgender or someone that wants to be a drag queen, but it’s not that,”

Guitterez, founder and CEO of Lunar beauty told CNBC.

“I think right now people are still intimidated by the aspect of it.”

Gutierrez’s makeup tutorials and product reviews have attracted nearly 5 million subscribers to his YouTube page. According to a note by the NPD Group, one setting powder product saw a 40% surge in sales after Gutierrez promoted it on his YouTube channel.

“It’s all about inclusivity and encouraging people to be a little more inclusive with both men and women,”

Said Gutierrez.

“I think that as time progresses and you see more men in beauty, it’ll get a little bit better and better.”



What You Need to Know About Red Light Therapy and Homeostasis

What You Need to Know About Red Light Therapy and Homeostasis

Our bodies are in constant need of replenishing our cells with oxygen, nutrients, and ATP energy to stay on top of our day to day activities. Also, the optimal function of our cells boils down to maintaining the balance that our body needs. This is also known as homeostasis.

Homeostasis Defined

The scientific definition of homeostasis is in a state of equilibrium, wherein the body’s chemical and physical processes are stable. The balance of the body is dependent on a plethora of factors, such as body temperature, calorie intake, level of blood sugar, the balance of fluid, and pH levels.

These factors are constantly changing and require regulation. They also adapt to changing environments like temperature, light, and activities. Reaching homeostasis requires balance for the body to reach its optimal state. This is present in humans' biology and animals' biology because it determines physical and mental performance, even stress response.

Homeostasis in Cellular Energy

The mitochondria break down food and oxygen to produce ATP energy for the body during the cellular respiration process. Healthy light intake is important in cellular energy to stimulate the mitochondria and efficiently produce ATP energy without inflammation and oxidative stress that may disrupt the cellular respiration process. Red and NIR light therapy enhances cellular and mitochondrial function to ensure that the cellular respiration process works efficiently.

Homeostasis in Body Temperature

Our bodies respond to changes in external temperature through sweating and shivering. These internal temperature processes regulate the body to maintain a temperature balance. The normal body temperature is about 98.6 degrees Fahrenheit. When the body is at a normal temperature, it’s easier to perform well. It can also indicate homeostasis and balance in the body, which we naturally try to achieve. On the other hand, experiencing a fever or being exposed to the cold can make it hard to function well for a long time.

Homeostasis and Calcium Levels

The body’s calcium is usually found in the bones and teeth, but the calcium in the blood requires constant maintenance at about 10 mg/dL. Calcium is essential for blood circulation, coagulation, and bone mineralization. When calcium is low, you may suffer from an irregular heartbeat and other health risks. Meanwhile, when calcium is high, the body may feel exhausted and sluggish because of the nervous system's inactivity. Skeletal, endocrine, and digestive systems in the bodywork hand in hand to maintain basic calcium homeostasis and balance.

Imbalance in the Body

The natural and continuous goal of the body in homeostasis, but many factors are at play. When we use our digestive, respiratory systems, and all the other organs, we need the necessary energy to process nutrients from food, oxygen, and light. The bodily systems are interdependent with one another and need each other to maintain balance.

When one system is lacking, the body naturally compensates by getting from another system to maintain balance. An example is a homeostasis in calcium levels in the bloodstream, which relies on food intake. If the diet lacks calcium, the body gets calcium from the bones, which technically regulates the calcium needed in the bloodstream, but eventually, it will make the bones weak and brittle.

The resourcefulness of the body to shift functions is a great deal. Still, in the long run, it may lead to serious health problems, possibly building up deficiencies and difficulties over time. It is imperative to be aware of the body’s balance and how diet, exercise, and light exposure are interconnected.

Healthy Light’s Effects on Biological Balance and Good Health

Light empowers the cells and enhances the cellular respiration process, creating ATP energy more efficiently. Aside from being essential for our life on earth, having enough light intake is an indication of biological balance. In fact, not getting your regular dose of sunlight may result in inflammation, sluggishness, off circadian rhythms, and poor sleeping habits. Most of the time, people don’t get enough light from their environment since they stay indoors and are surrounded by artificial light.

Being indoors is not how bodies are designed. We are programmed to thrive when our cells intake a good amount of healthy light. Not enough sunlight exposure can make the body imbalanced and lead to decreased energy production and Vitamin D.

Red Light Therapy and Homeostasis

You must be intentional in spending time outdoors to ensure that your body gets the amount of healthy light it requires. However, given the circumstances and limitations that we have, most people really do not get enough natural light, which red light therapy can solve.

Red light therapy is a non-invasive treatment that delivers red and NIR light wavelengths to the skin and cells and helps the mitochondria in cells produce enough ATP energy. Red light therapy helps keep the body and cells balanced, giving enough energy and power to the body even if there’s not enough light in the environment.

Final Thoughts

Our bodies function better when we reach biological balance or homeostasis. A balanced cellular environment indicates good health, and getting healthy light is an important variable to biological balance, on top of exercise, diet, and sleep. Red light therapy helps promote homeostasis and improve overall health by supporting a more efficient cellular environment. Red and NIR light wavelengths stimulate the mitochondria, producing more ATP energy that empowers the body.

If you want to read more about red light therapy and its benefits, you may go to our red light therapy blog. On the other hand, if you want to see our red light therapy devices breakdown, please don’t hesitate to browse through our catalog.

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How Effective is Blue Light Therapy for Spider Veins?

How Effective is Blue Light Therapy for Spider Veins?

Medical spas often recommend Blue light therapy for spider veins because they don’t have to be administered by trained doctors. And, yes, after several expensive sessions, you might start seeing a difference. The most effective method to treat spider veins is Sclerotherapy. We’ll also discuss the benefits of using Sclerotherapy is an effective alternative.

What are Spider Veins?

Before discussing how to treat spider veins with blue light therapy or sclerotherapy, we need to discuss what causes spider veins.

Spider Veins, scientifically called Telangiectasias, are a small network of blood vessels visible just under the skin's surface. They are called “spider veins” because they look like red spider webs.

Spider veins generally occur on the legs, feet, thighs, and face. They can also cause slight pain and discomfort.

Causes and Dangers of Spider Veins

While spider veins aren’t dangerous in and of themselves, they can indicate underlying vein disease.

Vein Disease, also known as Chronic Venous Insufficiency, is a disease in which the valves in the veins malfunction. The valves are usually supposed to act as one-way doors and facilitate blood flow to the heart. However, when they malfunction, blood flows back down and pools around the legs. This can put pressure on the veins and lead to spider veins or varicose veins.

While spider veins themselves aren’t dangerous, vein disease is hazardous and needs to be treated immediately. If left untreated, venous insufficiency can result in bleeding, skin infections, and ulcers.

In the worst-case scenario, vein disease can also lead to Deep Vein Thrombosis, a medical condition in which blood clots in the veins. If the clotted blood breaks, it can get carried to the lungs, leading to a potentially fatal condition called Pulmonary Embolism.

What is Blue Light Therapy for Spider Veins?

Blue Light Therapy for spider veins is a method in which blue light or laser is used to treat spider veins. The laser is non-UV in nature and emits photons that generate heat. The heat can destroy the damaged blood vessel over time. As such, the damaged vein shrinks and eventually dissolves.

Advantages of Blue Light Therapy for Spider Veins

The only time that blue light therapy for spider veins has an advantage over sclerotherapy is when it comes to the foot or face.

Both the face and the foot are dense with venous-arterial connections. When using Sclerotherapy, the Sclero has to be injected into the veins. Injecting it into the arteries can be dangerous. Most conservative physicians prefer not to use Sclerotherapy for spider veins in the face or foot.

As such, it’s better to go for blue light therapy for spider veins in the face or foot.

Sclerotherapy: An Alternative to Blue Light Therapy for Spider Veins

Sclerotherapy is the most effective and permanent method to treat spider veins. It is a minimally-invasive procedure in which a medicine called Sclerosant is injected into the damaged vein.

The Sclerosant inflicts some chemical damage to the veins, which leads to the vein walls sticking together and eventually closing up. The blood is then routed to healthier veins, and the damaged vein eventually gets reabsorbed.

Advantages of Sclerotherapy for Spider Veins

There are multiple advantages of using Sclerotherapy to treat spider veins:

  • The process is minimally-invasive and non-surgical in nature.
  • Sclerotherapy doesn’t hurt or cause much discomfort.
  • It works immediately, and you don’t need to come back for multiple treatment sessions.
  • It can get rid of spider veins permanently.
  • The entire process takes just about 30 minutes.
  • You can resume your daily activities immediately after.
  • It is cheaper than Blue Light Therapy.


Red Light Therapy for Enhanced Cellular Function

Red Light Therapy for Enhanced Cellular Function

The one thing we have in common with animals, plants, and other living organisms is that we are all made of tiny little cells. The intricate human body in itself houses trillions of cells. Without cells, there wouldn’t be any life on Earth at all.

In this article, we discuss cellular anatomy and cellular function. Here, we understand how light plays a role in the support and acceleration of cellular respiration.

What is a cell?

Think of cells as the basic building block of all living organisms. As the smallest unit of life, cells contain many parts, each with a different and specific function. The command center of the cell is called the nucleus that contains the human DNA.

As these cells combine to form into an organism, they become responsible for vital activities like nutrient intake, energy production, structure building, and hereditary material processing. They make sure that your body gets enough energy and nutrients to function 24/7.

What is ATP?

One essential activity that our cells do for us is by taking in oxygen and nutrients to fuel body energy. This energy unit that is converted by the cells is called Adenosine Triphosphate (ATP) Energy.

The ATP itself is a molecule packed with high energy that empowers cellular function. ATP is required by the body to do every activity. Other cells that do more strenuous activities like muscle cells would need more ATP than others. The ideal optimal cellular function would allow cells to produce and use enough energy to achieve body balance or homeostasis.

How is ATP produced?

The mitochondria are the powerhouses of the cell. They are responsible for the production of ATP. Aside from cellular energy, this double-membrane powerhouse does protein synthesis, cell signaling, and cell apoptosis. ATP is produced with oxygen (aerobic) or without oxygen (anaerobic), the former being more beneficial because it converts more energy. Thus, 95% of cellular energy goes through an aerobic process.

Our cells go through a process called Aerobic cellular respiration to convert oxygen, food, and water into the body’s energy currency, which is ATP. This process is a well-organized metabolic pathway that consists of four stages. Our bodies take in nutrients from the food we eat for the first two stages to convert them into carbon compounds. Then for the next steps, these carbon compounds are transformed into the energy that our cells use.

How does light therapy support cellular function?

Light can sometimes be less attributed to improve our body’s physiology. However, light has benefits that go beyond aesthetic and technological purposes. Just like how light plays a role in plants' photosynthesis, it also benefits human cellular function.

Red light therapy from Kaiyan Medical composes of Red and Near-Infrared Wavelengths that aid in the Mitochondria's function to produce more ATP energy. It works by increasing the number of Mitochondria in our cells and by boosting their function.

The electron transport chain heavily governs the cellular respiration process. Red Light therapy has photons that can boost the mitochondria to function better through the Cytochrome C Oxidase. It plays an essential role in the cellular respiration process by improving the cell's electron transfer process. In this way, more ATP can be produced by the body for an enhanced cellular function.

As mentioned earlier, oxygen plays an essential role in the cellular respiration process. The infamous Nitric Oxide can take the rightful place of oxygen to limit ATP production that causes stress and cellular death. Red light therapy also gets rid of a harmful roadblock to ATP in the dissociation of Nitric Oxide and the Cox. The photons from Red light therapy prohibits the production of nitric oxide.

The effect that Red Light therapy does on our body is that by improving cellular function, our body can achieve these benefits:

  • Improved blood Flow
  • Increased Energy Build up
  • Enhanced Healing Response
  • Reduced Inflammation
  • Reduced Stress
  • Balanced Cellular Function

As you do daily activities such as eating, drinking, walking, or working out, think of the massive role that your cellular system plays to make these activities possible. In this way, you can put conscious efforts into improving your cellular system through a healthy diet and lifestyle and by integrating Red Light Therapy.

References:

https://www.healthline.com/health/red-light-therapy#how-does-it-work?

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215870/

https://www.medicalnewstoday.com/articles/325884

https://www.britannica.com/science/cell-biology

https://www.britannica.com/science/mitochondrion

https://www.nationalgeographic.org/media/cellular-respiration-infographic/

The Effect of Green & Red Light Therapy on Hearing

The Effect of Green & Red Light Therapy on Hearing

Low-level laser therapy

Low-level laser therapy (LLLT) has been practiced for over 20 years in Europe and has been introduced in the United States as a treatment for pain and postsurgical tissue repair. It has been proposed that laser energy in the red and near-infrared light spectrum may aid in the repair of tissue damage. A proposed mechanism for this therapeutic effect is the stimulation of mitochondria in the cells to produce more energy through the production of adenosine triphosphate.

Studies in humans have investigated the effects of LLLT on both hearing loss and tinnitus, with equivocal results. Some studies have found an improvement in hearing thresholds and tinnitus symptoms.

The Subjects

A total of 35 adult subjects were enrolled in the study. Two subjects withdrew from the study due to loss of interest and/or scheduling difficulty. The data from three additional subjects were not included in the analysis. One subject yielded unreliable audiometric and speech understanding data, speech scores could not be obtained from one subject with a profound hearing loss, and calibration problems compromised data from the third subject. Data from the remaining 30 subjects were included in the analyses. The experimental protocol was approved by the Institutional Review Board of The University of Iowa, and written informed consent was obtained from all participants.

The Device

An Erchonia EHL laser was used to provide the laser stimulation. The device was a portable unit that consisted of a hand-held probe and a main body. The probe contained two laser diodes. One diode produced light in the green part of the visible light spectrum (532 nm wavelength), and the other diode produced light in the red part of the visible light spectrum (635 nm wavelength). Both diodes produced energy levels of 7.5 mW (class IIIb). The laser beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. A second Erchonia EHL device served as the placebo. It was identical to the treatment device, except that the laser diodes were replaced with nonfunctioning standard light-emitting diodes.

The Groups

The study used three groups: treatment, placebo, and control. Subjects were pseudorandomly assigned to one of the three groups.

Initial group assignment was random with occasional adjustment to ensure that the three groups were similar in terms of number of participants, female/male ratio, mean age of participants, and mean pure-tone audiometric thresholds. The treatment group received the laser treatment protocol using the functional laser device. The placebo group also received the laser treatment protocol, but using the nonfunctioning laser device. The control group made similarly timed visits to the laboratory but received no real or feigned “treatment.” The study used a repeated-measures design, with each subject taking a battery of pretests, followed by treatment followed by a battery of posttests.

Analysis

Data were obtained from both ears of each subject. Since no obvious differences were seen between left and right ears, data from both ears were combined in the following analyses. Strictly speaking, this likely violates the statistical assumption of independent sampling, since the test results from left and right ears of a single subject are likely to be highly correlated. None of the statistical tests used in the analyses are robust to the assumption of independent sampling, and the effect of including both ears is likely to be that of artificially increasing the sample size, making it more likely that a statistically significant result will be found. All statistical tests were conducted using a significance level of .

Conclusions

No statistically significant effect of LLLT on auditory function was found, as assessed by pure-tone audiometry, speech understanding, and TEOAEs in this test. Additionally, no individual subjects showed any clinically significant change. It remains possible that other methods of LLLT could have an effect on hearing. The type of device used was not the best one for this type of study. Further research elucidating the anatomic and physiologic bases for therapeutic effects of LLLT on hearing are needed before further clinical testing is warranted.

More References

Clinical Study | Open Access. Volume 2013 |Article ID 916370 | https://doi.org/10.1155/2013/916370

ClinicalTrials.gov (NCT01820416)

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Light Therapy Helping the Crisis that’s Being Ignored: PTSD

Light Therapy Helping the Crisis that’s Being Ignored: PTSD

Post-traumatic Stress Disorder

Post-traumatic stress disorder (PTSD) is a mental health condition that’s triggered by a terrifying event — either experiencing it or witnessing it. Symptoms may include flashbacks, nightmares, and severe anxiety, as well as uncontrollable thoughts about the event.

Most people who go through traumatic events may have temporary difficulty adjusting and coping, but with time and good self-care, they usually get better. If the symptoms get worse, last for months or even years, and interfere with your day-to-day functioning, you may have PTSD.

Getting effective treatment after PTSD symptoms develop can be critical to reduce symptoms and improve function.

PTSD symptoms are generally grouped into four types: intrusive memories, avoidance, negative changes in thinking and mood, and changes in physical and emotional reactions. Symptoms can vary over time or vary from person to person

The Light Helper, the EMDR Therapy

Eye Movement Desensitization and Reprocessing (EMDR) therapy is an interactive psychotherapy technique used to relieve psychological stress. It is an effective treatment for trauma and post-traumatic stress disorder (PTSD).

During EMDR therapy sessions, you relive traumatic or triggering experiences in brief doses while the therapist directs your eye movements.

EMDR is thought to be effective because recalling distressing events is often less emotionally upsetting when your attention is diverted. This allows you to be exposed to the memories or thoughts without having a strong psychological response.

Over time, this technique is believed to lessen the impact that the memories or thoughts have on you.

What are the Benefits of EMDR Therapy?

People who are dealing with traumatic memories and those who have PTSD are thought to benefit the most from EMDR therapy.

It’s thought to be particularly effective for those who struggle to talk about their past experiences.

Although there is not sufficient research to prove its effectiveness in these areas, EMDR therapy is also being used to treat:

How Does EMDR Therapy Work?

EMDR therapy is broken down into eight different phases, so you’ll need to attend multiple sessions. Treatment usually takes about 12 separate sessions.

Phase 1: History and treatment planning

Your therapist will first review your history and decide where you are in the treatment process. This evaluation phase also includes talking about your trauma and identifying potential traumatic memories to treat specifically.

Phase 2: Preparation

Your therapist will then help you learn several different ways to cope with the emotional or psychological stress you’re experiencing.

Stress management techniques such as deep breathing and mindfulness may be used.

Phase 3: Assessment

During the third phase of EMDR treatment, your therapist will identify the specific memories that will be targeted and all the associated components (such as the physical sensations that are stimulated when you concentrate on an event) for each target memory.

Phases 4–7: Treatment

Your therapist will then begin using EMDR therapy techniques to treat your targeted memories. During these sessions, you will be asked to focus on a negative thought, memory, or image.

Your therapist will simultaneously have you do specific eye movements. The bilateral stimulation may also include taps or other movements mixed in, depending on your case.

After the bilateral stimulation, your therapist will ask you to let your mind go blank and notice the thoughts and feelings you’re having spontaneously. After you identify these thoughts, your therapist may have you refocus on that traumatic memory, or move on to another.

If you become distressed, your therapist will help bring you back to the present before moving on to another traumatic memory. Over time, the distress over particular thoughts, images, or memories should start to fade.

Phase 8: Evaluation

In the final phase, you’ll be asked to evaluate your progress after these sessions. Your therapist will do the same.

How Effective is EMDR Therapy?

Multiple independent and controlled studies have shown that EMDR therapy is an effective treatment for PTSD. It’s even one of the Department of Veterans Affairs’ strongly recommended options to treat PTSD.

A 2012 study of 22 people found that EMDR therapy helped 77 percent of the individuals with a psychotic disorder and PTSD. It found that their hallucinations, delusions, anxiety, and depression symptoms were significantly improved after treatment. The study also found that symptoms were not exacerbated during treatment.

An older study trusted Source that compared EMDR therapy to typical prolonged exposure therapy, found that EMDR therapy was more effective in treating symptoms. The study also found that EMDR therapy had a lower dropout rate from participants. Both, however, offered a reduction in the symptoms of traumatic stress, including both anxiety and depression.

Several small studies have also found evidence that EMDR therapy is not only effective in the short term but that its effects can be maintained long term. One 2004 study evaluated people several months after they were given either “standard care” (SC) treatment for PTSD or EMDR therapy.

During and immediately after treatment, they noticed that EMDR was significantly more efficient in reducing symptoms of PTSD. During the three- and six-month follow-ups, they also recognized that participants maintained these benefits long after the treatment had ended. Overall, the study found that EMDR therapy gave people a longer-lasting reduction in symptoms than SC.

EMDR therapy has proven to be effective in treating trauma and PTSD. It may also be able to help treat other mental conditions like anxiety, depression, and panic disorders.

Some people may prefer this treatment to prescription medications, which can have unexpected side effects. Others may find that EMDR therapy strengthens the effectiveness of their medications. In Kaiyan Medical, we can help you create your own EMDR therapy device.

References
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The Top 100 Medical Device Acronyms you Should Know

The Top 100 Medical Device Acronyms you Should Know

In collaboration with the work of Jon Speer in July 19, 2020

Every industry in the world uses acronyms, and the overlap between multiple fields can be a source of confusion for professionals. There’s no room for confusion in the medical device industry, as a miscommunication could potentially lead to a product defect or adverse event with serious consequences.

Here the list:

21 CFR PART 11

Part 11 of Title 21 in the Code of Federal Regulations, commonly referred to as 21 CFR Part 11 or Part 11 for shorthand, establishes the acceptance criteria by FDA of electronic records, electronic signatures and handwritten signatures executed to electronic documents.

Compliance of quality systems with 21 CFR Part 11 requirements applies to the medical device industry, in addition to pharmaceutical, biotechnology, and other FDA-regulated industries.

21 CFR PART 820

FDA maintains quality system regulations, or QSR, found in 21 CFR Part 820, which establishes the quality system requirements for all medical device manufacturers in the United States. Manufacturers are required to establish and maintain a quality system that is appropriate for the medical device to ensure both the safety and efficacy for its intended use, per the requirements of 21 CFR Part 820.

483 OBSERVATION

A 483 observation, or “inspectional observation,” is a notice issued by an FDA inspector to flag potential regulatory violations found during a routine inspection. A Form 483 observation may be issued regarding any violation under FDA jurisdiction. Failure to demonstrate handling of the observed problems can be escalated to a warning letter.

510(K) PREMARKET NOTIFICATION

A 510(k) is a regulatory premarket submission made to FDA for a Class I, II, or III medical device that doesn’t otherwise require premarket approval. The purpose of a 510(k) submission must demonstrate a safe and effective device that is substantial equivalent to an existing legally marketed device.

APPLICATION LIFECYCLE MANAGEMENT (ALM)

Application Lifecycle Management, or ALM, involves the specification, design, development and testing of software tools. ALM systems are used to manage quality and demonstrate compliance during the software delivery process.

AUDITING ORGANIZATION (AO)

An Auditing Organization, or AO, is responsible for auditing medical device manufacturers to evaluate conformity with quality management system requirements and other medical device regulatory requirements. An AO may be an independent organization or a Regulatory Authority (RA).

AOs participating in the Medical Device Single Audit Program (MDSAP) may conduct a single regulatory audit of a manufacturer which satisfies the relevant requirements of RAs participating in MDSAP.

APPROVED SUPPLIER LIST (ASL)

An Approved Supplier List, or ASL, is an internal list kept by medical device manufacturers to record suppliers known to meet the quality and performance standards of the manufacturing organization.

BILL OF MATERIALS (BOM)

A Bill of Materials, or BOM, is a complete list of raw materials, assemblies, and subassemblies required to produce a device, as well as the quantities required for each. A BOM is required to carry out change management processes for a medical device.

COMPETENT AUTHORITY (CA)

A Competent Authority, or CA, is a body within the government of a Member State in the European Union. A CA transposes the requirements of Europe's medical device regulation (MDR) into the national law of each Member State. For example, the Federal Institute for Drugs and Medical Devices (BfArM) is the the CA for Germany.

CONFORMITY ASSESSMENT (CA)

A Conformity Assessment, or CA, is carried out by an EU Notified Body to determine that a medical device is safe and performs as intended by the manufacturer. Medical devices must pass a conformity assessment in order to obtain CE Marking.

COMPUTER-AIDED DESIGN (CAD)

Computer-Aided Design (CAD) software allows device manufacturers and designers to draft detailed designs, including precise specifications and measurements. CAD software files can be stored on a digital database for reference.

CORRECTIVE AND PREVENTIVE ACTION (CAPA)

Corrective and Preventive Action, or CAPA, is a quality system process carried out by a medical device organization to reduce and/or eliminate potential sources of risk and regulatory non-conformance or noncompliance.

CE MARKING (CE MARK)

A CE Marking, or CE Mark, certification must be obtained by medical device manufacturers for product distribution into the European Union (EU) marketplace. CE Marks are issued by third-party organizations, known as a Notified Bodies, and indicate compliance with the applicable EU medical device regulations (MDR).

EUROPEAN COMMITTEE FOR STANDARDIZATION (CEN)

The European Committee for Standardization, or CEN, is a public standards organization that develops standards for medical devices for sale in the European Union (EU). CEN can be compared to the Food and Drug Administration (FDA), which maintains and enforces medical device regulations in the U.S. marketplace.

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

The Center for Devices and Radiological Health, or CDRH, is a branch of the U.S. Food and Drug Administration (FDA) responsible for overseeing the approval of medical devices for sale in the U.S. market and also monitors the manufacturing, performance, and safety of those medical devices.

CLINICAL EVALUATION REPORT (CER)

A Clinical Evaluation Report, or CER, provides clinical evidence that a medical device will perform as expected, such that no safety issues occur while using it. European regulations require medical device manufacturers to perform a conformity assessment, of which include CER documentation, in order to legally market a product in the EU.

COST OF QUALITY (COQ)

Cost of Quality, or CoQ, is a system for measuring the financial impact that a quality system and its processes has on a business. Medical device companies can use CoQ to calculate potential savings and weigh those against the costs associated with internal process improvements.

COMPUTER SYSTEM VALIDATION (CSV)

Computer System Validation, or CSV, is a process used to demonstrate that computer systems, including hardware and software, used in medical device manufacture meet the regulations outlined in 21 CFR Part 11.

CURRENT GOOD MANUFACTURING PRACTICES (CGMP)

Current Good Manufacturing Practices, or cGMP, are minimum standards provided by FDA for manufacturing processes and facilities. The FDA cGMP standards establish a framework for medical device manufacturers to follow and allow for greater flexibility in achieving various quality requirements.

DOCUMENT CHANGE ORDER (DCO)

A Document Change Order, or DCO, is a formalized process in medical device change management. The DCO process involves change requests to be made within an organization to a document or system in a standardized, traceable manner.

DE NOVO

The De Novo regulatory pathway is a classification process that uses a risk-based methodology for novel medical device to be granted market entry for sale in the U.S. For a de novo submission to be granted by FDA, general controls must indicate that the device is safe and effective for its intended use.

DEMING CYCLE

The Deming Cycle is a methodology for monitoring quality efficacy and serves as a basis for traditional quality assurance. The Deming Cycle model is comprised of four parts: plan, do, study, and act. These parts are often summarized as PDSA.

DESIGN CONTROLS (DC)

Design Controls or DC, as defined by FDA in 21 CFR 820.30, are a systematic process that ensures specific design requirements are met by documented procedures that control the design of the medical device. The purpose of DCs is to demonstrate that a medical device is safe, effective, and performs as expected.

DESIGN DOSSIER (DD)

A Design Dossier, or DD, includes all contents of the technical file (TF), which describe a device’s design, manufacturing, and performance, as well as the documentation that demonstrates conformity with applicable regulatory requirements.

DESIGN OF EXPERIMENT (DOE)

A Design of Experiment, or DoE, is a method for medical device manufacturers and engineers to validate internal processes and predict process variability in order to improve and maintain product quality.

DESIGN FOR MANUFACTURE (DFM)

A Design for Manufacture, or DFM, is a process for optimizing the design of a medical device for manufacturing. A DFM takes into account the cost of manufacture, as well as regulatory compliance and product performance.

DESIGN HISTORY FILE (DHF)

A Design History File, or DHF, contains all documentation related to the design and development of a medical device. Medical device manufacturers in the U.S. market are required by law under FDA 21 CFR Part 820 to maintain a DHF.

DEVICE HISTORY RECORD (DHR)

The Device History Record, or DHR, acts as a record of production for a medical device and demonstrates it was manufactured according to information stored in the device master record (DMR). Manufacturers operating in the U.S. are required under CFR Part 820.184 to maintain a DHR, which contains information such as acceptance records for units or batches of products, unique product identifiers, and product counts.

DEVICE MASTER RECORD (DMR)

A Device Master Record, or DMR, is a record of all the information and specifications required to produce a medical device. The DMR contains instructions for manufacturing, drawings and specifications for devices, and requirements for labeling and packaging. Manufacturers are required by FDA to maintain a DMR under CFR Part 820.181.

DOCUMENT MANAGEMENT SYSTEM (DMS)

A Document Management System, or DMS, is a tool used to store and manage documents related to medical device development, as well as track any changes made to documents throughout the product lifecycle on an ongoing basis. A DMS is not synonymous with a Quality Management System, or QMS, which stores documents but also has a regulatory compliance focus.

ENGINEERING CHANGE ORDER (ECO)

An Engineering Change Order, or ECO, is a process that is triggered when an issue is raised with a medical device in terms of performance, cost-effectiveness, or the process of manufacturing the device. An ECO is typically followed by an analysis to determine whether action should be taken. Depending on the nature of the change, an ECO may lead to a CAPA investigation.

ESTABLISHMENT INSPECTION REPORT (EIR)

An Establishment Inspection Report, or EIR, is made by FDA in the event a Form 483 is issued following an inspection. The next steps after receiving an official EIR from FDA will be determined by the severity of the issues observed, as well as the 483 response. If significant deficiencies are observed, FDA may decide to issue a warning letter.

ENTERPRISE RESOURCE PLANNING (ERP)

Enterprise Resource Planning, or ERP, refers to the management of business processes within the organization of a medical device organization. This is often carried out with the use of ERP tools that gather and organize business data and automate processes related to human resources and business practices.

IN VITRO DIAGNOSTIC REGULATION (IVDR)

The European Commission's new IVDR 2017/746, which is shorthand for In Vitro Diagnostic Regulation, is Europe's new regulation for in vitro diagnostic devices that is scheduled to go into effect 26 May 2022. The IVDR requires all existing IVD devices being sold in the EU market to undergo recertification for compliance with the new requirements, which supersede the previously held directives for in-vitro diagnostic devices (IVDD).

EU MEDICAL DEVICE DIRECTIVE (MDD)

MDD is the Medical Device Directive for medical devices sold in the European marketplace, which was replaced in 2017 by the medical device regulation (MDR. The purpose of the directive was to harmonize laws and standards around medical devices marketed in the European Union.

EU MEDICAL DEVICE REGULATION (EU MDR)

EU MDR is a common abbreviation for the medical device Regulation (EU) 2017/745, which mandates the quality and safety requirements for medical devices produced and marketed in the European Union (EU). The EU medical device regulation supersedes the previously held medical device directives (MDD) that were in place up until 2017 and places strong emphasis on a total product lifecycle approach.

EUROPEAN DATABASE ON MEDICAL DEVICES (EUDAMED)

The European Database on Medical Devices, or EUDAMED, is a database developed by the European Commission to facilitate compliance with European medical device regulations. It's intended to function as a multipurpose system for registration, collaboration, and communication for multiple stakeholders in the medical device industry.

FOOD AND DRUG ADMINISTRATION (FDA)

The Food and Drug Administration, or FDA, is a federal agency of the U.S. Department of Health and Human Services. The FDA is responsible for approving medical devices for manufacture and distribution within the U.S. Medical device manufacturers operating within the U.S. market are subject to FDA inspections and compliance with the requirements outlined in Title 21 of the Code of Regulations.

FAILURE MODES AND EFFECTS ANALYSIS (FMEA)

Failure Modes and Effects Analysis, or FMEA, is a method used to identify failures in a design or process associated with a medical device. FMEA is distinct from ISO 14971, the international standard for medical device risk management. The FMEA method can be broken into two parts: PFMEA for processes, and DFMEA for designs.

FAULT TREE ANALYSIS (FTA)

Fault Tree Analysis, or FTA, is an analytical method aimed at identifying points of failure and risk within a quality system. In medical device manufacture, FTA can be applied throughout the course of risk management activities to identify possible sources of risk.

FREEDOM TO OPERATE (FTO)

Freedom to Operate, or FTO, refers to product infringement on intellectual property. Device manufacturers typically declare whether they have FTO in each market in which they plan to sell a new product.

GENERAL SAFETY AND PERFORMANCE REQUIREMENTS (GSPR)

Medical device manufacturers are required to comply with the General Safety and Performance Requirements (GSPRs) of the new EU MDR. The regulation splits GSPRs into three chapters, general requirements, requirements regarding design and manufacture, and requirements regarding the information supplied with the device.

HAZARD IDENTIFICATION (HID)

Hazard Identification, or HID, is a risk management process in which device manufacturers determine whether situations, processes, or items associated with the production of their device may have the potential to cause harm.

INVESTIGATIONAL DEVICE EXEMPTION (IDE)

An Investigational Device Exemption, or IDE, is an FDA exemption that allows an investigational device to be used for testing a device against premarket approval standards. An investigational device can be used to gather data on the safety and effectiveness of the device, and this data is submitted as an IDE for review by FDA.

IEC 60601

IEC 60601 is a standard pertaining to electrical medical equipment. Any medical device containing electronics must pass the necessary requirements outlined in IEC 60601.

Programmable Electrical Medical Systems, or PEMS, is a key part of what's covered in IEC 60601. PEMS consists of software, firmware, and equipment that can be programmed to carry out functions that aid medical care or treatment. The standard also covers mechanical safety, labeling, and risk management.

IEC 62304

IEC 62304 is a software framework that outlines software engineering and documentation practices. It is also recognized by FDA and provides a risk-based framework that can be used throughout entire medical device software lifecycle.

INSTRUCTIONS FOR USE (IFU)

Instructions for Use, or IFU, are instructional materials used to convey relevant information to the end user. These materials must take into account the capabilities and limitations of the end user in order to communicate instructions as concisely and objectively as possible.

INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)

The International Medical Device Regulators Forum, or IMDRF, is a voluntary working group of international medical device experts whose purpose is to harmonize medical device standards and regulations. The IMDRF supersedes the Global Harmonization Task Force.

INSTALLATION QUALIFICATION (IQ), OPERATIONAL QUALIFICATION (OQ), AND PERFORMANCE QUALIFICATION (PQ)

Installation Qualification, Operational Qualification, and Performance Qualification are terms that pertain to medical device software and equipment validation. IQ relates to the proper installment of software or equipment, OQ concerns meeting the necessary regulatory requirements, and PQ has to do with compliance of the software or equipment performance.

INSTITUTIONAL REVIEW BOARD (IRB)

An Institutional Review Board, or IRB, is a body that oversees human medical research in the U.S. and ensures that the human rights of all subjects are protected. An IRB has the authority to approve or disapprove research or to request modifications to research practices.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO)

The International Organization for Standardization, or ISO, is a non-governmental organization of experts providing voluntary international standards, based on the subject matter expertise of members, to enable and promote innovative solutions to worldwide challenges.

ISO 13485:2016

ISO 13485:2016 is the internationally harmonized standard for medical device quality management systems (QMS). To align with ISO 13485:2016, QMS contents should address the specific, applicable requirements outlined in the standard, in addition to the applicable regulatory requirements according to the markets where the medical device will be manufactured and marketed.

ISO 14971:2019

ISO 14971:2019 is the latest version of the international standard for medical device risk management. The globally recognized standard offers best practices for using a proactive approach to risk management throughout the entire lifecycle of a medical device.

ISO 9001

ISO 9001 is an international standard that specifies the requirements for a quality management system. Belonging under the umbrella of the ISO 9000 standard, 9001 is the only one that offers a certification pathway for manufacturers. This standard assumes a specialized focus on ensuring users receive good-quality products and services.

IN VITRO DIAGNOSTIC (IVD) DEVICES

IVD refers to In Vitro Diagnostic devices. As defined in IVDR (EU) 2017/746, IVD can describe devices or equipment “intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body.”

MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE)

Manufacturer and User Facility Device Experience, or MAUDE, is a database for medical device electronic reporting (eMDR) submitted to the FDA by manufacturers, importers, device user facilities, health care professionals, patients, and consumers.

MEDICAL DEVICE REPORTING (MDR)

Medical Device Reporting, or MDR, refers to a surveillance tool maintained by FDA that is used to monitor the performance and safety of medical devices after being placed on the market. MDR provides voluntary reporting capabilities to both medical device manufacturers and consumers for public-use.

MEDICAL DEVICE SINGLE AUDIT PROGRAM (MDSAP)

The Medical Device Single Audit Program, or MDSAP, is a program allowing medical device manufacturers to gain access into multiple global markets through one audit event. There are currently five active participating regions of MDSAP, including Australia, Brazil, Canada, Japan, and the United States.

MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA)

Medical Device User Fee Amendments, or MDUFA, refers to changes made to the fee structure in which medical device companies are expected to pay to FDA in order to register their establishments and devices. These fees also apply to application or notification submissions made to the FDA.

MEDICAL DEVICE QUALITY MANAGEMENT SYSTEM (MDQMS)

A Medical Device Quality Management System, or MDQMS, is a quality management system built from the ground up for the medical device industry. Unlike a legacy QMS or ad hoc system, a MDQMS typically includes templates and workflows that align with medical device industry requirements and best practices.

MANUFACTURING RESOURCE PLANNING (MRP)

Manufacturing Resource Planning, or MRP, is a way of compiling, organizing, and planning various activities carried out by a medical device manufacturer (or with any business). The method involves simulating hypothetical scenarios to ensure resources are being used effectively. This term has fallen out of use in recent years and may also be referred to as ERP.

NOTIFIED BODY (NB)

A Notified Body, or NB, is a third-party auditing organization that assesses the quality and conformity of medical device products seeking market entry into the European Union.

NONCONFORMANCE REPORT (NCR)

A Nonconformance Report, or NCR, is used to document non-conforming material observed during quality control activities or inspection. A NCR details the identified issue(s) of nonconformance, the severity and impact of the non-conformance, how it occurred, and how nonconformance will be managed to prevent recurrence.

NONSIGNIFICANT RISK (NSR)

Nonsignificant Risk, or NSR, is a measure of risk as outlined by ISO 14971. Determining whether a risk is significant or nonsignificant involves assessing the probability of direct harm, probability of harm from not using the device, and probability of harm from misinformation.

OWN BRAND LABELING (OBL)

Own Brand Labeling, or OBL, occurs when a manufacturer sells a medical device in the EU that already has a CE Marking and does so under its own brand.

ORIGINAL EQUIPMENT MANUFACTURER (OEM)

An Original Equipment Manufacturer, or OEM, is an organization that produces goods which are used as subparts in products of a third-party company, which then sells the end products to consumers.

PERSONS RESPONSIBLE FOR REGULATORY COMPLIANCE (PRRC)

The European Commission requires manufacturers to designate at least one person with the requisite expertise in the field of medical devices from within their organization as the Person Responsible for Regulatory Compliance (PRRC).

PRODUCT DEVELOPMENT (PD)

Product Development, or PD, is the pre-market process of building a medical device. In the medical device industry, this process encompasses the design and development of a product.

PRODUCT DATA MANAGEMENT (PDM)

Product Data Management, or PDM, is the handling of data as it relates to a medical device within a software system. Modern medical device companies often use PDM tools to compile product data and automate management protocols.

PRODUCT LIFECYCLE MANAGEMENT (PLM)

In the manufacturing sector, Product Lifecycle Management, or PLM, is a system for managing and overseeing the development and distribution of a product. This process applies to the inception, design, regulatory approval, manufacturing, marketing, and post-market phases of medical devices until the product is no longer on the market.

PREMARKET APPROVAL (PMA)

Premarket Approval, or PMA, is the regulatory pathway to market required for Class III devices under FDA regulations. The PMA submission process typically involves clinical trials with human participants, as well as laboratory testing, to demonstrate the safety and efficacy of the device.

POST-MARKET SURVEILLANCE (PMS)

Post-Market Surveillance, or PMS, is the process of monitoring a medical device after it has gained market entry for sale and distribution of use for use by patients within the marketplace. PMS involves gathering data and feedback on the performance of a device on the market, and it is a mandatory process for compliance with most regulations and standards, including 21 CFR Part 820, EU MDR, and ISO 13485:2016.

PROOF OF PRINCIPLE (POP)

Proof of Principle, or POP and also known as Proof of Concept, is the demonstration that the initial concept behind a medical device is feasible. The POP typically includes criteria for success that must be met in order to proceed with product development.

PRODUCTION PLANNING AND CONTROL (PPC)

Production Planning and Control, or PPC, is a process used to organize the production, including design and development activities, and the manufacture of a medical device. A PPC process is usually comprised of inputs, outputs, and control systems. Regulations for design and development planning are found under FDA CFR 21 Part 820.30.

QUALITY ASSURANCE (QA)

Quality Assurance, or QA, is a method used to prevent defective, nonconforming products. QA professionals engage in activities intended to improve the product development and testing processes, as well as maintaining compliant marketing and distribution processes.

A quality management system can be considered as a QA tool itself, as it serves as a single source of truth for all quality policies and procedures for the final product.

QUALITY CONTROL (QC)

While QA focuses on the process, Quality Control, or QC, focuses on the product. QC is system for identifying defects in a medical device during the post-production phase, prior to product distribution. The goal of quality control is to ensure the product conforms to specified requirements and will meet expected performance criteria upon end user interface. QC and QA are complementary aspects of a QMS.

QUALITY MANAGEMENT SYSTEM (QMS)

A Quality Management System, or QMS, is an organizational tool for implementing and maintaining activities, documents, and tasks as it relates to responsibilities, procedures, processes, and resources. A QMS is instrumental in achieving regulatory compliance and in producing safe and effective medical devices. At minimum, a quality system should include design controls, risk management, document control and records management, and supplier management.

QUALITY SYSTEM INSPECTION TECHNIQUE (QSIT)

The Quality System Inspection Technique, also known as the QSIT method, is a type of FDA inspection that uses a top-down approach to reviewing the four main subsystems within a company's QMS. The top-down approach used by the FDA inspector begins with reviewing the company's procedures before drilling down into the quality records for those processes. The quality records serve as proof the company is following its written procedures.

QUALITY SYSTEM RECORD (QSR)

A Quality System Record, or QSR, is a record that acts as a source file for all documentation, procedures, and records that are located within a QMS. Medical device companies can use their QSR as a reference to navigate other aspects of their QMS. QSR can also refer to Quality System Regulation, shown below.

QUALITY SYSTEM REGULATION (QSR)

The Quality System Regulation, or QSR, for medical devices in the U.S. is outlined in FDA 21 CFR Part 820. The QSR requirements are based on methods for facilities, and controls used for, carrying out all phases of processes throughout the lifecycle of a medical device. These aspects include design, manufacture, packaging, labeling, storing, installing, and servicing of medical devices intended for use by humans.

REGULATORY AFFAIRS (RA)

Regulatory Affairs, or RA, professionals in the medical device industry play a strategic role throughout the product lifecycle, such as ownership of a company's go-to-market strategy for satisfying legal requirements of product commercialization, regulatory submission protocol, and postmarket surveillance methods. The RA role serves a critical function for effectively communicating and executing appropriate regulatory strategies to ensure compliance.

RISK ANALYSIS (RA)

Risk Analysis, or RA, is a method used in risk management to identify specific risks associated with a design, procedure, or process used in the manufacture of a medical device. The RA process will include identifying the medical device, the persons involved, the scope of the risk analysis, and relevant date(s). Preliminary hazard analysis, FMEA, and fault tree analysis are all methods used to carry out risk analysis for a medical device.

RISK MANAGEMENT (RM)

Risk Management, or RM, is a process used by medical device companies to identify, control, and prevent hazards and risks/sources of harm that might arise during the use of a medical device. The internationally recognized standard for medical device RM processes are outlined in ISO 14971:2019.

RESEARCH USE ONLY (RUO)

Research Use Only, or RUO, is a term used to indicate that a medical device product or instrument does not have an intended medical purpose and instead is to be used for research purposes only. Devices used for research in IVD product development are often labeled RUO.

SOFTWARE AS A MEDICAL DEVICE (SAMD)

Software as a Medical Device, or SaMD, is a class of software used for medical functions, without needing a hardware component to serve that function. An application or software that's used to diagnose, cure, prevent, or mitigate disease are all considered to be classes of SaMD.

SUPPLIER CORRECTIVE ACTION REQUEST (SCAR)

A Supplier Corrective Action Request, or SCAR, is a formal notice sent to a supplier by a medical device company upon the observance of issues related to nonconforming products or materials. Such issues impact the quality of the provided goods, and the purpose of the SCAR is to solicit action from the supplier to identify and correct the issue(s) raised.

SUBSTANTIAL EQUIVALENCE (SE)

Substantial Equivalence, or SE, is a regulatory requirement by FDA for market clearance of new products through a 510(k) premarket submission. To declare substantial equivalence, a company must prove their device is as safe and effective as a similar predicate device. SE is required for regulatory submissions for which a premarket approval (PMA) is not required.

SAFE MEDICAL DEVICES ACT (SMDA)

The Safe Medical Devices Act, or SMDA, is a law which passed in 1990 establishing HHS as the governing authority over device user facilities to report incidents in which a medical device may have caused or contributed to the serious injury, illness, or death of a patient.

STANDARD OPERATING PROCEDURE (SOP)

A Standard Operating Procedure, or SOP, is an internal procedure created by an organization to standardize a routine process for ease of repeatable. A SOP is typically a written document comprised of a series of prescriptive instructions to be followed by individuals and teams. Medical device companies are required to create and maintain SOPs for routine processes as part of their QMS.

STATISTICAL PROCESS CONTROL (SPC)

Statistical Process Control, or SPC, is a method used to control a process through the use of statistical techniques. This involves compiling data from a process and building cause and effect models to predict and account for various outcomes.

SIGNIFICANT RISK (SR)

Significant Risk, or SR, is a measure of risk as defined by ISO 14971. Any device that poses a serious risk to the health or safety of a human subject is categorized as SR.

SINGLE-USE DEVICES (SUDS)

Single-Use Devices, or SUDs, are disposable devices intended to be used for a singular event or procedure for one patient only. These devices are to be disposed after use rather than sanitized and re-used.

SUMMARY TECHNICAL DOCUMENTATION (STED)

Summary Technical Documentation, or STED, is format manufacturers can use to record required information about how a medical device was designed, developed, and manufactured for submission to a Regulatory Authority or Notified Body to demonstrate conformity. The STED format represents the documentation required for Technical Files.

TECHNICAL FILE (TF)

A Technical File, or Design Dossier  for Class III devices, includes specific details about a medical device's design, composition, intended use, function, and clinical evaluation. TF are a key requirement of obtaining CE marking for a device.

UNIQUE DEVICE IDENTIFICATION (UDI)

Unique Device Identification, or UDI, is a system established by the FDA to catalog and identify each individual device for sale in the U.S. market by assigning a custom identifier that can be read by both humans and machines. A UDI is distinct from a Universal Product Code (UPC), as the UDI is used to identify a medical device on the FDA website via the AccessGUDID portal.

UNIVERSAL PRODUCT CODE (UPC)

A Universal Product Code, or UPC, is a code printed on retail packaging consisting of a barcode and a 12-digit number. The code can be used to track inventory for retailers and is considered to be an alternative tracking method to UDI, the official identification system used by FDA.

VERIFICATION AND VALIDATION (V&V)

Verification and Validation, also known as V&V, are activities for testing and confirming whether a medical device meets the design procedures and is ready to be released for manufacture. Design verification ensures you designed the device correctly and design validation ensures you designed the correct device. These processes tend to involve careful tests, trials, and analyses.

VOLUNTARY ACTION INDICATED (VAI)

Voluntary Action Indicated, or VAI, is a term used by the FDA in establishment inspection reports (EIR) to indicate regulatory action is not required, following the observance of objectionable conditions or practices during an inspection. On the contrary, Official Action Indicated (OAI) would indicate regulatory or administrative action is required by FDA to correct an issue found during an inspection.

WARNING LETTER (WL)

A Warning Letter (WL) is an official notice made by FDA in response to regulatory violations that have been escalated from a 483 observation. Violations may include anything from wrongful claims about the device to missing design controls. A WL will provide a detailed explanation of the violation and what is required of companies for a corrective action plan.

WORK IN PROGRESS (WIP)

Work in Progress, or WIP, is a term used to refer to partially finished goods in manufacturing or within a design history record (DHR). Inventory that has entered the manufacturing process and can no longer be classed as raw materials but is not yet a finished product is classed as WIP.

The information provided in this article is for educational purposes only and is not intended to support the safety or effectiveness of any medical device, or diagnose, treat, cure, audit, procedure, quality standard or prevent any disease.