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.
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.
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 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.
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 .
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.
Color Light therapy is based on the idea of restoring balance by applying color to the body. Its history is rooted as far back as the Mayan culture.
In India, Ayurveda, an ancient form of medicine practiced for thousands of years, is based on the idea that every individual contains five elements of the universe that are present in specific proportions unique to each individual, including their personality type and constitution. When these elements are out of balance, Ayurveda works with the energies inherent in the colors of the spectrum to restore this balance.
In ancient Egypt the art of healing with color was founded in the Hermetic tradition, the Ancient Egyptians and Greeks used colored minerals, stones, crystals, salves, and dyes as remedies, and painted treatment sanctuaries in various shades of color.
In China, traditional Chinese medicine incorporates color to be associated with each organ and elemental system. This healing method looks at the idea that every individual is a balance. The first color wheel was invented by Sir Isaac Newton. He split white sunlight into red, orange, yellow, green, cyan, and blue. He then joined the two ends of the color spectrum together to show the natural progression of colors.
Light Therapy has been valued throughout history as a remarkable source of healing. Today, the therapeutic applications of light and color are being investigated in major hospitals and research centers worldwide. Results indicate that full-spectrum, ultraviolet, colored, and laser light can have therapeutic value for a range of conditions from chronic pain and depression to immune disorders.
Light Therapy has been reported, as part of a healthy lifestyle, to temporarily reduce swelling, relieve pain, decrease inflammation, accelerate open wound healing and greatly reduce overall recovery after medical/surgical procedures. Patients have demonstrated an increased range of motion, decreased muscle tension and spasm, and improved circulation.
Rejuvenating LED light therapy can be used for temporary pain management such as joint and back pain, sore or torn muscles, sprains, arthritis, post-surgical scars, burns, wounds, and more. When used with infrared technology, light therapy (phototherapy) is one of the most effective and non-invasive ways to improve overall wellness.
Light therapy is also used to temporarily relieve Seasonal Affective Disorder (SAD). SAD affects individuals when the lack of sunlight results in seasonal depression. Phototherapy helps with SAD by resetting the internal biological clock (Circadian rhythms), helping individuals sleep better, and regulate their mood. Even companies, such as GE and Philips, have created phototherapeutic products to improve and regulate mood.
Light therapy is also a growing treatment for anti-aging. Many individuals have seen a temporary reduction in the appearance of fine lines, wrinkles, crow’s feet, and age spots.
Light therapy is “effective at improving the appearance of the face, neck, and chest by reducing the signs of aging, wrinkles and age spots”, says Web M.D. Combined with infrared therapy, LED phototherapy can be a great way to revitalize skin.
Color is light split into different wavelengths vibrating at different speeds and at different frequencies. Objects that ABSORB all wavelengths and DO NOT reflect are black in nature. Objects that REFLECT all wavelengths and DO reflect are white in nature. Between black and white lies COLOR. Colors are wavelengths of energy that, to us, appear as color because of the potential and capabilities of the object to either absorb or reflect the energy.
In the early 1990s, RLT was used by scientists to help grow plants in space. The scientists found that the intense light from red light-emitting diodes (LEDs) helped promote the growth and photosynthesis of plant cells.
The red light was then studied for its potential application in medicine, more specifically to find out if RLT could increase energy inside human cells. The researchers hoped that RLT could be an effective way to treat the muscle atrophy, slow wound healing, and bone density issues caused by weightlessness during space travel.
You may have heard of red light therapy (RLT) by its other names, which include:
Red is called “The Great Healer”. So far is the most popular light therapy. To wind down before bed, use red light. “The color signals that it’s night, which may encourage the body to produce melatonin,” says Michael Breus, Ph.D., an advisory board member for SleepScore Labs.
Red light can also improve your workout. Just one to five minutes of exposure to red and infrared light right before exercise boosted strength and prevented soreness, says Ernesto Leal-Junior, Ph.D., the head of the Laboratory of Phototherapy in Sports and Exercise at Nove de Julho University in Brazil. “Certain wavelengths of red and infrared light-660 to 905 nanometers-reach skeletal muscle tissue, stimulating the mitochondria to produce more ATP, a substance that cells use as fuel,” he says.
Green is the universal healing color. Originally, the color of love. Green is midway in the color spectrum; therefore, it contains both a physical nature and a spiritual nature, in equal balance and in equal harmony.
Gazing at green light can reduce chronic pain (caused by fibromyalgia or migraines, for example) by up to 60 percent, according to a study in the journal Pain, and animal studies have shown that the beneficial effects can last up to nine days. “Looking at green light seems to lead to an increase in the body’s production of enkephalins, pain-killing opioid-like chemicals. And it reduces inflammation, which plays a role in many chronic pain conditions,” says researcher Mohab Ibrahim, M.D., Ph.D.
More studies are needed before doctors can make recommendations on how and how often to use green light to treat migraines and other pain, and Dr. Ibrahim says you should see a physician before trying to treat yourself at home. But at this point research indicates that exposing yourself to an hour or two every night-either by using a green light bulb in a lamp or by wearing glasses fitted with tinted optical filters-may decrease migraines and other types of chronic pain
Helps to treat and prevent hyper-pigmentation by inhibiting the production of excess melanin which then prevents it from traveling to the surface. It will help break up the melanin clusters that are already on the surface.
Yellow helps awaken mental inspiration arousing a higher mentality. Thus, it is an excellent color for nervous or nerve-related conditions or ailments; fueling the solar plexus. Yellow has a very enriching effect upon the intellect. Yellow can be used for conditions of the stomach, liver, and intestines. It can help the pores of the skin by repairing scarred tissue. These rays have an alkalizing effect which strengthens the nerves. Awakening, inspiring, and vitally stimulating the higher mind promoting self-control. Typical diseases treated by yellow are constipation, gas, liver troubles, diabetes, eczema, and nervous exhaustion. Providing clarity of thought, increasing awareness, stimulating interest, and curiosity yellow energy is related to the ability to perceive or understand.
The yellow is used for treating redness, flushing, irritation, and Rosacea. It may also reduce the appearance of the tiny blood vessels on the nose and face.
Blue light therapy technology is an additional option for the treatment of acne. Research has shown in-office and at-home systems produce positive results.
“Blue light therapy effectively helps alleviate this common skin condition affecting 50 million Americans and 94 percent of all females, according to Judith Hellman, MD, a board-certified dermatologist, in practice in New York City. Dr. Hellman, who practices medical dermatology and specializes in dermatological surgery, laser surgery, and anti-aging skin treatments, explains how the blue light treatment system works for acne, its uses, and her clinical experience with the technology.
It is used as a gentle acne treatment to control oil production in the skin as well as reduce inflammation. It also promotes the synthesis of protein and collagen.
Orange Light
Orange has a freeing action upon the mind, relieving repression. Because orange is a blend of red and yellow, it combines physical energy with mental wisdom, inducing a transformation between lower physical reaction and higher mental response. Thus, it is often referred to as “The Wisdom Ray.” Orange is warm, cheering, and non-constricting.
Through orange, we are able to heal the physical body (red) and, at the same time, induce within the mind (yellow) greater understanding. Orange helps assimilate new ideas. Orange is the best emotional stimulant, helping to remove inhibitions paving independent social behavior. Bring joy to your workday and strengthen your appetite for life. Orange aids in repairing inflammation of the kidneys, gallstones, menstrual cramps, epilepsy, wet cough, and all sinus conditions.
Purple Light
Violet is the last color we can see before light passes on to ultra-violet. Violet purifies our thoughts and feelings giving us inspiration in all undertakings. The violet energy connects us to our spiritual self bringing guidance, wisdom, and inner strength and enhances artistic talent and creativity. Leonardo da Vinci proclaimed that you can increase the power of meditation ten-fold by meditating under the gentle rays of Violet, as found in church windows.
Light therapy uses colors for their proposed wellness abilities in treating emotional and physical disturbances. Light therapy is based on the premise that different colors evoke different responses in people. For example, some colors are considered to be stimulating, whereas others may be soothing. Color therapy has been suggested for many uses, based on tradition or on scientific theories. Consult with a health care provider before using color therapy for any use.
Infrared Light
Infrared light penetrates to the inner layers of the skin at about 2 to 7 centimeters deep. Hence, it reaches the muscles, nerves, and even the bones. Many studies have shown that a frequency of infrared light, with wavelengths from 700 to 1,000 nanometers, is best used for healing inflammatory conditions.
The use of electricity for healing purposes began in 2,750 BC when people used electric eels to give electric shocks. Electricity and magnetism were used in people with just little success. However, in 1975, transcutaneous electrical stimulation (TENS) was developed to treat chronic pain. It was not until recently that infrared therapy was developed to improve wound healing, reduce the pain caused by arthritis, boost endorphin levels, and bioactivate neuromodulators.
Infrared therapy technology allows people to harness the benefits of the sun, without being exposed to harmful ultraviolet rays. Also, infrared therapy is safe and effective, without adverse side effects. As a matter of fact, infrared light is safe and is used even for infants in neonatal intensive care.
Infrared light is absorbed by the photoreceptors in cells. Once absorbed, the light energy kickstarts a series of metabolic events, triggering several natural processes of the body on a cellular level.
Kaiyan Medical
In Kaiyan, we are in love with light therapy. We believe in the natural balance in our bodies. We develop devices such as the Aduro mask which will provide you with the full range of color light therapies.
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As humans, we are made of energy and fueled by light. While nutrition and exercise play a role in our well-being and health, light plays a crucial role in us functioning optimally. New and groundbreaking research is unearthing a new understanding of how our cells function and the evidence points to the power of light.
Through technological advancements in science, it’s discovered that our bodies operate similar to a battery. Wavelengths of light give us power, while our overall health determines our ability to receive and maintain the energy from light. And this is where light therapy comes into the equation.
Science has proven that our bodies interact with specific wavelengths that benefit our bodies in various ways.
Red light therapy devices, such as light therapy masks, shine red and near-infrared light onto the skin, stimulating the production of adenosine triphosphate (ATP) within the mitochondria. By stimulating ATP, damaged cells heal, and new cells are produced faster than normal. But we’ll talk more about that in-depth a little later.
Red light therapy comprises both red light and infrared wavelengths, penetrating through the skin’s layers, right into the cells. Red light wavelengths boost collagen and elastin and improve cell communication. It penetrates superficially and helps aid various skin conditions.
Near-infrared wavelengths stimulate healing, increase mitochondrial function, and improve blood flow and tissue oxygenation. Near-infrared wavelengths penetrate deeply into the body.
At the core of your body’s healing capabilities are the mitochondria. The mitochondria play a vital role in your internal organs and tissue, including the liver, skin, heart, and muscles. It’s in charge of the body’s energy supply via ATP (adenosine triphosphate).
With both working together, they provide energy to our body and maintain the cell cycle and growth. This is why you’ll often hear the mitochondria referred to as the “powerhouse of the cell.”
Here's how the mitochondria is affected by red light:
Interestingly, our body weight is made of 70% water, with 99% of our bodies' molecules also made of water, making it a powerful component in red light therapy treatment.
Research by Prof Gerald Pollock of the University of Washington proved that water adjacent to a cell is structured water, also known as EZ water. This specific water forms a separation of charge, functioning in the body as positive and negative poles - similar to a battery.
While we’ve been talking about red light therapy, what does it actually mean? Typically, “red light therapy” refers to natural light treatments which deliver red and near-infrared wavelengths as natural sunlight using LEDs or cold lasers.
While you may think red light therapy includes all colors of light, it doesn’t. The term doesn’t include blue or white light, and it isn’t equivalent to full-spectrum light. Red light therapy doesn’t rely on heat, differentiating it from other light-based treatments such as infrared saunas and heat therapy.
Red light therapy is also known as RLT, photobiomodulation (PBM), phototherapy, LED therapy, LED light therapy, infrared therapy, low-level laser therapy, or low-level light therapy (LLLT).
As stated before, red light therapy works to heal the entire body and functions on multiple levels.
Red light therapy affects the body in multiple ways, including bodily systems:
Fascia
Fascia is the thin casing of connective tissue that surrounds virtually every organ, muscle, nerve fiber, blood vessel, and bone in place. While it performs as an internal structure for your body, the fascia also contains nerves, making it almost as sensitive as skin.
The fascia may look like a layer of tissue; however, it’s made up of interwoven layers of collagen and elastin fibers. The fascia is overlooked, yet over recent years, it has been the key to understanding how changes in one area of our body affect others. Red light therapy works to improve communication within the fascia network.
Gut-Brain Axis
The gut-brain axis connects the emotional and cognitive centers of the brain with peripheral intestinal functions. Recent research discovered the importance of gut microbiota concerning these interactions.
Red light therapy can positively influence mood and neuropsychological issues by the following:
Immune System
Red and near-infrared light penetrate through the skin into the cells, which results in low-dose metabolic stress that strengthens the cells’ anti-inflammatory and natural defense systems. In turn, the body becomes resilient to infections.
Safe and low exposure to red light therapy improves the body’s response to external viruses and bacteria. Red light therapy can influence the immune response in the following ways:
Circulatory System
Red light therapy is scientifically proven to increase the micro-circulation of blood and support the circulatory system as a whole by stimulating the development of new capillaries which carry oxygen throughout the body.
Proper oxygen supply and flow are essential for the proliferation of cells, protein synthesis, tissue restoration, inflammatory response, and angiogenesis. In addition, circulation is also responsible for waste elimination, specifically degenerated cells.
Nervous System
The nervous system includes the brain, spinal cord, neurons, and neural support cells, which is your body’s command center. It controls your movements, automatic responses, and other body systems such as digestion and breathing.
Red light therapy affects the nervous system in the following ways:
For all forms of nerve damage, red light therapy offers non-pharmaceutical treatment options.
Stem Cells
Red light therapy shows impressive results regarding stem cell growth, maximizing the potential of stem cell implantation for various medical needs. Therefore, red light therapy may show positive results after surgery to stimulate stem cells which repair tissues and organs.
In studies, red light therapy has proven to stimulate mesenchymal stem cells in bone marrow, enhancing their ability to reach the brain. This research shows the possibilities of using red light therapy to heal degenerative conditions, including Alzheimer’s, Parkinson’s disease, and dementia.
It’s clear red light therapy provides multilevel treatment to the body, becoming a popular natural and holistic option for both professionals and consumers, but where did it come from?
Light therapy technology isn’t new; it’s been around for decades as NASA experimented with red light therapy during the 1980s and 1990s. Over the past 10-20 years, red light therapy reached a breakthrough in LED lighting technology, allowing the production of safe and affordable clinical and at-home devices.
In 2016, Kaiyan Medical became the first leading manufacturer of red light therapy of affordable FDA-approved and MDASAP-approved light therapy devices.
We mentioned red light therapy being a holistic treatment option, but what does that mean. Holistic medicine is a full-body approach to healthcare. By focusing on the body, mind, and soul, the body receives the full support and care it needs to function optimally.
Principles of Holistic Medicine
Holistic medicine is based on the following principles:
The purpose of treatment is to identify the underlying cause of the disease, rather than treating only the symptoms.
While there are endless benefits the body receives from red light therapy, here are the six main benefits.
Photobiomodulation, in other words, red light therapy, has proven effective against carpal tunnel syndrome, mucositis, neck pain, menstrual cramps, temporomandibular joint pain, and neuropathic pain from amputation. It also significantly reduces the pain of hypersensitivity while improving sensorimotor function.
These improvements come after anti-inflammatory cells populate the injured area, providing long-lasting pain relief. In addition, it’s also been shown to provide effective relief by affecting the following:
Red light therapy has proven to be highly effective in rapidly treating wounds from burns, scars, bedsores, ulcers, surgery incisions, and diabetic neuropathy.
NASA strongly supports this claim as this technology was used in treating wounds. Red and near-infrared light proves effective in all four phases of the wound-healing process:
These processes are regulated by various factors connected via nitric oxide (NO) signaling release, adjusted by light energy.
An issue the body encounters when trying to heal a wound is low oxygen flow, and red light increases the flow of oxygen, speeding up the natural healing process. By reducing inflammation and increasing oxygenation of the wounded area, blood vessels can form, rapidly repairing the area, lessening pain and scarring.
By reducing pain, red light therapy eliminates the reliant on pharmaceutical painkillers during the healing process.
The human body receives energy on the cellular level, maintaining communication between organs and ensuring disease resistance.
A strong immune system works to protect the body from harmful bacteria and viruses at all times. With red light therapy, the body receives a boost of support as it releases nitric oxide and melatonin, two components involved in DNA repair and antimicrobial.
This process is called hormesis. Red and near-infrared wavelengths penetrate through the skin into the cells, causing mild metabolic stress, which stimulates cells to activate their anti-inflammatory and antioxidant response.
With the support of red light therapy, the body is better prepared to fight infections. Numerous studies have proven red light therapy to have the following effects on the immune system:
Inflammation in the body can be acute and topical (short-term, resulting from sprains, infections, and accidents) or chronic and general (long-term, caused by ongoing conditions).
Acute inflammation is a healthy bodily response; however, chronic and general inflammation can negatively impact long-term health.
As of today, the current treatment for inflammation is NSAID or steroid drugs, both having a detrimental effect on the healing process and long-term health. Red light therapy stimulates the body to activate its natural healing mechanism, reducing the health risks of long-term drug use.
Red light therapy decreases the number of inflammatory cells, increases fibroblast proliferation (cells that synthesize collagen and other matrix macromolecules), stimulates angiogenesis (creation of new blood vessels), and activates the body’s anti-inflammatory, antioxidant response.
The following conditions are connected with chronic and acute inflammation, all proving promising results with red light therapy treatment:
Red light therapy is extremely popular in competitive sports and performance. It offers natural and non-pharmaceutical treatment, which applies to many areas of the body.
Aside from the overwhelming benefits on overall health, red light therapy encourages muscles growth and repair by stimulating the production of ATP, which aids in faster recovery and better performance.
Red light therapy used before training prepares and strengthens the body while aiding muscle recovery after training.
Here are the scientifically documented effects of red light therapy:
Seasonal affective disorder (SAD) is a form of depressions, impacting 5% of Americans, specifically during the winter when there’s less natural sunlight. SAD is also known as seasonal depression or winter blues.
Many people treat SAD symptoms via bright white light treatment, mimicking the sun’s light daily. However, researchers recommend natural light treatment, like red light therapy, to help with light deficiency. Over recent years, physicians recommend red light therapy alongside psychotherapy and medication.
While many people are using red light therapy devices for at-home treatment, red light therapy systems are found in many clinical and professional settings:
Skincare Professionals: Red light therapy is a popular skincare treatment among Hollywood celebrities, including Kourtney Kardashian, Julia Roberts, and Emma Stone. Leading skincare professionals like dermatologists and aestheticians use red light therapy to help promote collagen production, reduce wrinkles, and treat skin conditions.
Health Practitioners: Health practitioners from all specialties are incorporating red light therapy into their practice. Dentists use it to reduce inflammation, physicians for mental health conditions, and oncologists for cancer side effects.
Natural Health Experts: Leading voices in the health and wellness industry such as Dr. Sarah Ballantyne, Ben Greenfield, and Dave Asprey strongly support the use of red light therapy. Paleo and Keto health experts like Robb Wolf, Mark Sisson, Luke Story, and Dr. Anthony Gustin also support red light therapy.
Sports Medicine Pros: The National Sports Association of Sports Medicine (NASM) adopted red light therapy to treat sports injuries. Top trainers and doctors, including Dr. Troy Van Biezen and Dr. Ara Suppiah, use red light therapy to heal their athletes.
Elite Pro Athletes: Professional athletes worldwide, including NFL stars like Patrick Peterson, UFC champion Anthony Pettis, and gold medal gymnast Sanne Weavers use red light therapy to enhance performance and quicken recovery.
Fitness & Training: World-renown fitness trainers, including Lacey Stone and Jorge Cruise, use red light therapy to enhance athletic performance and muscle recovery.
Supportive Cancer Care: The Multinational Association of Supportive Care in Cancer (MASCC) recommends the treatment of red light therapy for oral mucositis (OM), a common symptom of cancer treatment.
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Today's customers expect nothing less than products of the highest quality, and it is incumbent on all manufacturers to assure this expectation is met. A proven technique for checking whether a manufacturing process is in control is a manufacturing audit.
A manufacturing audit is a comprehensive inspection of a process to determine whether it is performing satisfactorily. A manufacturing audit is usually limited to a small portion of units produced, but the manufacturing processes involved are reviewed thoroughly. An audit does not replace normal quality control efforts, but supplements them.
Medical audit is a systematic approach to peer review of medical care in order to identify opportunities for improvement and provide a mechanism for realizing them. Medical audit and clinical audit are often used interchangeably, but clinical audit might be considered to cover all aspects of clinical care-for example, nursing and the role of paramedical staff-whereas medical audit relates to practices initiated directly by doctors. It complements and may partly overlap financial audit, utilization review, and management of resources, but is primarily clinical, not managerial; its focus is the process and results of medical care rather than the use of resources and it is the responsibility of doctors rather than managers.
There are many reasons for conducting a manufacturing audit:
Kaiyan Medical got another audit supplier recognition by Made-in-China. We like to keep our audits and quality standards to the top in order to assure the best experience for our customers and clients
https://www.bmj.com/content/bmj/299/6697/498.full.pdf
COVID-19 has created challenges for nearly every market, and the medical device manufacturing industry is no exception. As the virus sweeps the globe, it’s becoming increasingly difficult for leaders to overcome the arising challenges and prepare for the future.
While I firmly believe the key to navigating this evolving landscape is putting quality at the forefront of all activities, a function made seamless through best of breed quality management tools, I was curious what other industry leaders had to say.
The following are some of their best tips for effectively leading and managing teams during the COVID-19 pandemic and preparing your organization for what’s to come.
Keep in touch. Let your people know where things stand with the business. At home or in the office practicing social distancing, each of your workers will be dealing with different issues, both private and professional. The distributed workforce requires even more channels to help people stay connected.
“Leadership needs to provide regular communication, be transparent about the impact of the pandemic on your company, and set expectations with your team, investors, partners, and customers. There is a great deal of uncertainty in the world, and clarity from management is one of the keys to a healthy organization.” — Paul Grand, CEO, MedTech Innovator
Be sensitive to employees’ personal situations. Every member has their own worries and family needs during this crisis. Review goals and when needed realign expectations to match current circumstances.
Balance the content. Focus on efficiency in meetings to ensure your team still has time to do their work and manage their personal situation. The recommended time for meetings should be 15 minutes with no more than 4 people per meeting
Office time should be reduced. To avoid conflicts, make sure yo manage expectations. Be clear about your expectations and the expectation from your team during these challenging times. The last thing you want to do is have misunderstandings or conflicts with a good working team.
The key purpose of a leader is to continuously motivate and support the team. Talk about work-life structures, supporting flexible working arrangements, and vocalizing empathy towards your workmates. As a leader, you must empower them to deliver their best work while being absolutely empathetic towards challenges in their life.
Focus on the fact that COVID-19 is temporary. The natural instinct may be to slow down and withdraw resources. Instead, this is an excellent time to strategically plan and dedicate time, staff, and resources to ensuring that the post-pandemic time capitalizes on key changes.
Just because you can’t conduct research the way you always have doesn’t mean you can’t conduct research at all. It is important to stay flexible with the research methods you use. Understanding the pros and cons of each method and their overall ability to contribute to your research goal is critical to conducting meaningful and useful research.
All companies are working to lead their teams through today’s challenges with confidence. By taking care of your team and keeping quality you will improve the teamwork collaboration, communication, and transparency.
We’ve all been in the search to help us achieve perfect skin. But is it just a dream, or can it really be achieved? It looks like having light shined on your face may be the most important part of your skin routine.
Red light’s anti-inflammatory and collagen-building effects on the skin have been documented for years, showing its healing abilities. However, light therapy is branching out, including other light spectrums such as green, blue, purple, and amber, for different healing abilities.
Ellen Marmur, a New York dermatologist, said, It has just enough variety that people stay excited to use it.” While many at-home devices are small and require multiple treatments to cover the entire face, masks help solve this issue.
“It makes people feel good, like they’re taking care of themselves,” Dr. Marmur said. “You can treat your skin while doing other things, so it’s easier to form the habit of doing it every day.”
LED therapy, known as photobiomodulation, can alter biological matter using varying wavelengths of light.
Jared Jagdeo, associate professor of dermatology and director of the Center for Phototherapy, SUNY Downstate Health Science University, studies LED therapy. “You can alter the skin through photo-damaging with lasers, or photobiomodulation, which is a much more gentle way of changing the way the skin functions,” he said.
When asked why red light works particularly well with skin, he said, “There’s a specific receptor in the mitochondria of the skin cells that red light specifically acts upon. And that’s why red light is an ideal wavelength for changing the way the skin functions.”
Red light can pass through the skin, deeply entering tissue and stimulating the cell’s mitochondria, which results in anti-inflammation and the skin’s rejuvenation. Collagen is also produced in the dermis, smoothing out wrinkles and plumping the skin.
While blue light doesn’t penetrate deeply into the skin, it kills acne-causing bacteria on the skin’s surface. Green light, on the other hand, focuses on melanocytes, reducing excess melanin production.
Eye safety is a valid concern, particularly because earlier this year Neutrogena recalled its LED mask over fears that it could cause eye injuries.
Brain S. Biesman, assistant clinical professor of ophthalmology, dermatology, and ENT at Vanderbilt University Medical Center in Nashville, states that most red light therapy devices aren’t powerful enough to cause eye damage. “Just normal blinking and eye movements should be sufficient to protect the eyes,” he said. “But never stare at a bright light source.”
More Thoughts
“As far as the F.D.A. is concerned, if I use CO2 laser resurfacing, it better work because of the amount of risk involved,” said Suzanne Kilmer, a clinical professor of dermatology at the UC Davis School of Medicine in Sacramento and director of the Laser and Skin Surgery Medical Group.
“Compare that to a home device,” Dr. Kilmer said. “If it doesn’t kill you, blind you or make things much worse, it’s probably going to get approved. So it’s actually more incumbent upon the people selling home devices to show efficacy. You have to trust the people who are selling them.”
“LED is real, but it’s probably not optimized yet,” Dr. Kilmer said.
With light therapy, various factors help determine the amount of light your skin needs: the light’s strength, the distance from the skin, the length of time the device is used on the skin, and the natural color of your skin.
“Some of these lights on the market are very weak, and they may not have enough energy output to actually have a biological effect,” Dr. Jagdeo said. “Imagine a glow stick. It produces a color. But you could shine it on your face all day, and it’s not going to change the way your skin works.”
Moreover, the medical community hasn’t determined the standardized dose for treating skin conditions such as hyperpigmentation and acne at home. Dr. Marmur chose her MMSphere dosing on Blu-U, an in-office blue light typically used as an alternative therapy for precancerous lesions.
“Consistent Sphere treatment for seven weeks will equal the energy given in the office with the Blu-U,” she said.
Another device, the Dr. Dennis Gross DRx SpectraLite FaceWare Pro, $435, releases red and blue light in a mask format, with each session lasting only three minutes. The mask’s LEDs are in contact with the skin, which may be a more effective treatment.
Dr. Jagdeo said, “This is a tremendously undertapped area in medicine. But LED light therapy is going to revolutionize the way home medical treatment is delivered for skin care over the next 10 to 15 years.”
If you’re considering developing your own LED facial mask, at Kayian Medical, our team of experts knows what they’re doing. We developed the Aduro mask, the top facial mask in the beauty industry with celebrities such as Julia Robert fans of the Aduro Mask. For more information, visit https://www.aduroled.com/.
Migraine is a neurological condition that can cause multiple symptoms. It’s frequently characterized by intense, debilitating headaches. Symptoms may include nausea, vomiting, difficulty speaking, numbness or tingling, and sensitivity to light and sound. Migraines often run in families and affect all ages.
People describe migraine pain as:
Migraine symptoms may begin one to two days before the headache itself. This is known as the prodrome stage. Symptoms during this stage can include:
The effects of green light on the brain have been researched and well-documented for years. The green light can reset the circadian rhythm through melatonin, the hormone that regulates our sleep-wake cycles. A special photoreceptor system in the human eye picks up light and elicits non-visual responses, sending signals to the brain to reset the body’s internal clock and altering melatonin production levels.
Long-time sufferers of migraines and other chronic pain conditions may benefit from exposure to LED green light. A new study, led by pharmacologist Mohab M. Ibrahim, M.D., Ph.D., found that the color green may be key to easing pain.
Ibrahim’s interest in studying the ameliorating effects of green light was inspired by his brother, who has dealt with severe headaches for several years. Instead of taking ibuprofen, his brother would sit in his garden and soak up the verdure of nature to ease the pain from his headaches.
“I wanted to see what is in his garden or in a garden, in general, that would make headaches better,” said Ibrahim, director of the Chronic Pain Management Clinic at Banner — University Medical Center Tucson.
In his clinical practice, Ibrahim also saw that his patients suffering from migraines and fibromyalgia had limited treatment options, and wanted to find a novel, non-invasive, nonpharmacological therapy.
In his study, which has yet to be published, Ibrahim exposed 25 migraine volunteers first to white lights for two hours as a control, then to green LED lights. He measured multiple parameters, including pain reduction, frequency of migraines or headaches, frequency of fibromyalgia flare-ups, pain intensity and duration, and quality of life.
On a scale of 0 to 10, with 0 indicating no pain and 10 the highest level of pain, migraine volunteers had an initial average baseline pain score of 8. After completing the green light therapy, their score dropped down to an average of 2.8. The frequency of headaches dropped from 19 to 6.5 per month, and the overall quality of life climbed from 48 percent to 78 percent.
“The best part about it … is the simplicity, the affordability and, most importantly, the lack of side effects,” Ibrahim said. “It’s a normal light. We’re not using a high-energy laser or anything like that.”
But if pain works through the nervous system, how exactly can green light, which works through the visual system, make people feel better?
New studies show that there are neuronal connections that span from the retina all the way to the spinal cord, passing through the parts of the brain that control and modulate pain. Green light changes the levels of serotonin and alters the endogenous opioid system, an innate pain-relieving system found throughout the central and peripheral nervous system, gastrointestinal tract, and immune system, said Bing Liao, M.D., a neurologist at Houston Methodist Hospital.
“The endogenous opioid system … allows the body to generate something similar to opioids and gives us a sensation of pain relief and happy feeling,” Liao said. “Research has found that, with green light, the receptors of the endogenous opioid system can increase production in the brain and body, and the hormone by itself can increase in production, as well. … It might be an explanation for why people feel good when they’re in a green environment.”
While more studies must be done to test the efficacy of green light therapy as a treatment for chronic pain, Ibrahim said he is trying to advance this therapy as a complement to current therapies.
“What this green light therapy offers is a non-invasive, non-pharmacological additional tool, so it might help reduce opioids,” he said. “I don’t think it will eliminate opioids, but at least it may reduce it enough. It may provide people just with extra help or extra relief so that they may not need the number of opioids that they’re on.”
https://www.ncbi.nlm.nih.gov/pubmed/28001756
https://www.ncbi.nlm.nih.gov/pubmed/21182447
https://www.ncbi.nlm.nih.gov/pubmed/23964217
https://www.ncbi.nlm.nih.gov/pubmed/7769534
https://www.ncbi.nlm.nih.gov/pubmed/26989758
If you are in the medical device industry in the U.S is likely that you heard of the 510(k) process. Those working on high-risk devices may be familiar with the PMA and De Novo pathways. These are the three options that are most commonly used by device companies.
However, there are seven major pathways that can be used to bring a medical device to market
So many people assume the 510(k) route is right for them because it is what everyone else does. Not always the case, and one of the other pathways might actually be better for your company.
Don’t look at the regulatory process as a series of hoops to jump through. Instead, focus on creating a regulatory strategy for your specific device that sets you apart from your competition.
The 7 major pathways to market in the U.S. include:
Are you developing a custom device for a specific patient? If so, your device falls under the Custom Device Exemption (CDE) pathway.
The product should be specifically designed to treat a unique pathology or physiological condition that no other device is domestically available to treat. It must be assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of the patient.
The device must be created or modified in order to comply with the order of an individual physician or dentist, typically in the form of a prescription. Not only must the clinician order the device, but it must also be used in the normal course of the professional practice of that physician or dentist.
The FDA even states that companies are limited to no more than 5 units per year of a particular device type.
CDE devices are exempt from PMA or 510(k) submission process but the company still needs to comply with the following regulations:
The Expanded Access program, often referred to as the compassionate use or emergency use provision. It allows an investigational device to be used, outside of a clinical trial, in situations where a seriously ill patient has few if any alternatives.
Although there are often ethical considerations, it may be appropriate to evaluate this option as a way to get early feasibility data for high-risk devices, especially when suitable animal models are unavailable. Like the HDE, this data could then be used to expand the label in the future.
Expanded access may be an appropriate pathway for you to choose when all the following apply:
The Product Development Protocol (PDP) is a subset of the PMA process that allows for another pathway for companies with devices in which the technology is well established in the industry.
This pathway allows the company to come to an early agreement with the FDA about how the safety and effectiveness of the device will be shown. The two parties are essentially creating a contract that describes design and development activities, including the outputs of these activities, and acceptance criteria for these outputs.
The company can follow the plan on their own time and report back to the FDA on the agreed-upon milestones. At the end of the process, the company is considered to have “completed” a PDP, which gives them an “approved” PMA.
The Premarket Notification 510(k) pathway is the most common route taken when launching a medical device. Almost all Class II devices and certain Class I devices will require a 510(k).
The purpose of a 510(k) submission is to provide the FDA with documented evidence showing that your medical device is substantially equivalent in terms of safety and effectiveness to a predicate device.
A predicate device is one that is already legally marketed and shares the same intended use and technological characteristics as your device. You are required to compare and contrast your device with the predicate by summarizing information from your design controls process, such as design features and verification testing.
The FDA typically processes 510(k) applications in 30–90 days. Depending on the robustness of your initial application, there may be a period of back and forth discussions, which can delay the process. It is important to plan ahead and provide all appropriate documentation at the time of initial submission.
Class III devices, and any device that cannot provide substantial equivalence to a Class I or Class II device through the 510(k) process, must use the Premarket Approval (PMA) pathway.
The PMA process is the most involved as scientific evidence, typically in the form of a clinical trial, is needed to prove the safety and effectiveness of your device.
The FDA will either approve or reject the application within 180 days. The different steps of the review process include:
If you are developing a lower risk, “novel” device, and struggling to find a predicate, the De Novo pathway might be the best option for you.
The De Novo pathway has actually been around since 1997 but many people do not know about it since it is not very commonly used. Companies that do not qualify for 510(k) clearance, due to the fact that they cannot provide substantial equivalence to a device on the market, should learn more about the De Novo pathway.
Since comparison to a predicate is not needed, companies have a “blank canvas” when it comes to labeling and can set a standard that may give them a competitive advantage over others. One of the key things to remember about the De Novo pathway is you must show your device presents low to moderate risk through a robust risk mitigation strategy.
The Humanitarian Device Exemption (HDE) pathway is for devices that are intended to treat or diagnose conditions or diseases that affect small or rare populations.
This pathway involves a two-step process. The FDA must grant a Humanitarian Use Device (HUD) exemption and the device company must then submit an HDE application to the appropriate review center.
Another important requirement is that there cannot be another comparable device on the market that shares the same intended use. The FDA will consider the following when determining if there are comparable devices on the market:
Part of the rationale for providing this pathway is there may not be a large enough patient population with clinical data to satisfy regular FDA requirements of safety and efficacy. Since these devices may be very crucial to patients with rare conditions, the FDA put it in place to do a proper review to determine if the device can be sold.
When it comes to pain, we could hardly avert it! Especially the muscle pain. Given that the human body has over 600 muscles, it is tough to avoid muscle pain. Evidently, one out of three Americans is affected by muscle pain annually.
Not only this, Musculoskeletal pain affects around 116 million Americans, which results in poor productivity, missed work or school, fatigue, and lost interest in work.
But doesn’t we treatments for this chronic pain? Of course, we do have several options. Currently, therapies available consist of non-steroidal anti-inflammatory drugs, steroid injections, pain medications, and surgery. Each of these has its own specific risk profiles.
What we need now is an effective solution that is less time-consuming, low risk, safe and non-invasive, and yet cost-effective. All these features are available in treatment; we call Low Laser Light Therapy (LLLT). Light therapy has been in the medical field over the past forty years. Light therapy has been demonstrated to lessen inflammation and edema, promote healing in a range of musculoskeletal pathologies. LLLT is being accepted around the globe. This is an advanced, cost-effective, non-invasive therapy for pain that could elevate the quality of life while reducing your financial strains. The causes of muscular pain are numerous. Hence, LLLT helps people from all fields like sports, fitness, medical, and even old age.
In this process, light with a wavelength in the red to the near-infrared region of the spectrum (660nm–905nm) is employed on the skin surface. The reason for using these wavelengths is that they have the ability to penetrate the skin and soft/hard tissues. From various conducted clinical trials, this treatment is proven to have a good effect on pain, inflammation, and repairing of the tissues. The therapy goes from 30 to 120 seconds or more a week, depending upon the pain's severity.
Based on the tissue condition, the therapy can go on for weeks or months. LLLT has resulted in relief and reduction of inflammation, pain relief, and accelerated tissue regeneration.
But how does the light actually work?
Do you know that many acute orthopedic conditions such as strains, sprains, muscular back pain, frozen shoulder, neck and back pain, etc., are amenable to Low Laser Light Therapy (LLLT)?
The Infra-Red light relieves pain in a different section of the body and increases relaxation sensation while also comforting the muscles. LLLT has been shown to enhance the multiplication of cells like fibroblasts, keratinocytes, endothelial cells, and lymphocytes. Fibroblasts and keratinocytes are two major cell types that respond to the inflammatory phase in the repair/regeneration process.
LLLT can enhance neovascularization, promote angiogenesis, and increase collagen synthesis to succor in the healing of acute and chronic wounds. The LED light sessions have shown the ability to heal skin, nerves, tendons, cartilage, and bones. Low-intensity LLLT stimulates mitochondria and also enhances the mitochondrial membrane potential.
The peripheral nerve endings of nociceptors (also known as the pain receptors), consisting of the thinly myelinated and unmyelinated, slow-conducting C fibers, lie within the epidermis. This complex network converts harmful stimuli into action potentials. Moreover, these nerve endings lie on the surface or superficial in nature, making the LLLT wavelength penetration work easy.
Hence, with the rise of chronic pain in different countries, it is imperative to validate cost-effective and safe techniques for managing painful conditions, allowing people to live active and productive lives. Light therapy is constantly evolving in relieving muscular pain. It improves the muscle's endurance, reduces muscle soreness, joint pain, and inflammation.
It’s time to let go of the pain!!
Experience the difference with light therapy from Kaiyan Medical.
https://pubmed.ncbi.nlm.nih.gov/12605431/
https://pubmed.ncbi.nlm.nih.gov/27472858/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4743666/
"Metastatic breast cancer can be a devastating diagnosis with high rates of relapse and death, and there are currently no effective therapies,"
Nalinikanth Kotagiri, MD, Ph.D. says.
"Despite newer treatments, many patients still succumb to the disease. Major limitations include acquired resistance to therapies and serious side effects from treatment. Due to the widespread location of breast cancer cells, particularly in the bone marrow, which harbors the tumor cells as well as vital stem cells, the risk of toxicity is even higher with conventional therapies. Therefore, new therapeutic strategies that selectively destroy tumor cells, increase treatment efficacy, prevent relapse and reduce side effects by sparing the healthy stem cells are necessary."
This is why Nalinikanth Kotagiri, MD, Ph.D., assistant professor in the James L. Winkle College of Pharmacy and a cluster hire for the Cincinnati Cancer Center, is hoping to study ways ultraviolet light can activate light-sensitive drugs to treat this invasive breast cancer and provide that light at the end of the tunnel patients yearn for.
Kotagiri has been awarded the Department of Defense Breast Cancer Breakthrough Award—over $600,000 for three years—to try to do just that. His project will focus on light-mediated therapies, which could activate light-sensitive drugs to target only the cancerous cells.
"Therapies such as photodynamic therapy (PDT), involving light and a photosensitizing chemical substance, which used in conjunction with molecular oxygen can cause cell death, offer a high degree of control that is effectively used to manage cancer in early to advanced stages," he says. "It operates on a simple principle where a light-sensitive drug, which is otherwise nontoxic, introduced into certain tissues can cause cell death when activated by light. Despite the promise of PDT, it can't penetrate tissue deeply so its use is limited. Also, current light-sensitive drugs require oxygen to be effective, but many tumors, including breast tumors, have pockets of low oxygen or grow in regions where oxygen is either low or absent, which could prevent effective application of PDT in cancer treatment."
However, Kotagiri says recent work in the lab has led his team to a "two-pronged approach" in addressing these issues.
"We've been using ultraviolet (UV) light from radionuclides (radioactive nuclide or atom), which are already used to image tumors and tissues, and tried to solve oxygen dependence by using metal-based light-sensitive drugs for depth- and oxygen-independent PDT," he says. "By replacing the external light source, such as lasers and lamps, with light from radionuclides as an 'internal' light source, we've been able to better control therapy in the body.
"This could mean more effective therapies with minimal toxicity to vital organs and tissues. Since radionuclides are used in imaging and locating tumors, we can now simultaneously image and treat breast cancer metastasis using the same radionuclide."
Using animal models, researchers in Kotagiri's lab will test whether radionuclide light activation of tumor targeting, light-sensitive drugs will destroy metastatic cancer cells—including those that are resistant to traditional therapies.
"Since how we're killing the cells is not dependent on a certain molecular pathway, the technology could be applicable to treat a wide variety of breast cancers," he adds. "This has the potential to be a common image-guided treatment strategy to treat patients in early as well as advanced stages of the disease, and because of the safety of this treatment strategy, it could be effectively used alongside other treatments, like chemotherapy and immunotherapy, without the risk of additional side effects.
"This could tremendously benefit patients, as it could potentially improve therapeutic outcomes in addition to setting a precedent to tailor other FDA-approved light-sensitive drugs as radionuclide activated therapies, expanding the scope and range of the diseases these drugs currently treat. If proven beneficial, this treatment could be ready for a patient population in 5 to 10 years, since all the materials involved have already been used in humans—this could be an exciting breakthrough."
ClinicalTrials.gov Identifier: NCT04418856
Besides what Kotagiri said, severe fatigue, depression, sleep problems and cognitive impairment are the most commonly reported side effects of cancer treatment. These aversive side effects are hypothesized to be related to the disruption of circadian rhythms associated with cancer and its treatment. Exposure to Bright White Light (BWL) has been found to synchronize the circadian activity rhythms but research with cancer patients has been scarce. Therefore, the proposed randomized control trial (RCT) will test if systematic light exposure (sLE) will minimize overall levels of cancer-related fatigue (CRF), depression, sleep problems and cognitive impairment among breast cancer patients undergoing breast cancer treatment (i.e., surgery, chemotherapy). SLE incorporates the delivery of harmless UV-protected BWL or Dim White Light (DWL - standard comparison in light studies) delivered to patients by using special glasses for 30 minutes each morning, during their treatment.
Learn more about the how to improve your circadian rhythm and light therapy & breast feeding
Now, you don’t often hear about cats getting depressed. In fact, most people don’t even know if depression is possible in animals.
A typical morning for cats usually involves purring, meowing, and stretching alongside family members. Then they’ll go to their favorite place to settle down in, and you continue with your day.
While we become comfortable with our cat’s daily routine, do we actually know our feline pets? What if your cat is depressed? Could you understand why? How can you help your cat overcome winter blues?
Cats are extremely sensitive to changes in light, more than humans. If there’s less light, a decrease in brain chemicals, including serotonin, can occur. When the weather changes to rain or snow, it’s not unusual for cats to feel the shift in sunlight.
Your cat, whether indoor or outdoor, may become depressed during the winter months. The lack of sunlight, less physical activity, and more time alone can contribute to feelings of restlessness or seasonal affective disorder (SAD).
SAD in felines occurs similar to humans, and it’s highly influenced by the amount of sunlight they’re exposed to daily.
If your cat has SAD, you may notice them behaving gloomy and moving slower than usual during the winter. However, when April and May roll around, they have more energy and appear happier.
The lack of sunlight is a serious problem as it reduces melatonin production, which results in depression, lethargicness, and anxiety. It also creates low levels of serotonin which acts as a neurotransmitter. With low serotonin, your cat may show signs of aggression, mood swings, and depression.
Achieving chemical balance is not easy, especially since serotonin cannot be given in a shot or pill. While your vet may prescribe a serotonin reuptake inhibitor (SRI), it comes with its side effects. A natural and non-invasive treatment option is light therapy, which adds natural sunlight into your cat’s environment to restore their chemical balance.
You’ll often heart veterinarians recommend light therapy as a treatment for SAD. Light therapy is an affordable, natural, and non-invasive treatment option that can help stabilize your animal’s emotional highs and lows. And it costs less than a year’s supply of pet food.
At Kaiyan Medical, we recommend treating your animal for 30 minutes every day with red light therapy. Cat and dogs suffer from many conditions such as inflammation, arthritis, and infections. Light therapy gives you the chance to help treat your pet and reduce their pain and suffering.
How does red light therapy actually help to treat animals? While you may think the answer is complex, it’s not. Red light therapy delivers red and infrared light into the animal’s cells, boosting the body’s natural ability to heal.
Using either LEDs or LASER diodes, light penetrates through the skin, entering the body’s cells. Photoreceptors in your animal’s cells absorb the light’s energy, enhancing the natural healing process by stimulating the cells’ energy production.
The use of varying lights helps treat different areas of the body. For example, red light is easily absorbed by tissue rich in hemoglobin, helping to heal surface wounds.
Near-infrared light penetrated into deeper tissues within the body, entering muscles, joints, bones, tendons, and ligaments for extensive treatment. Combing red, green, and near-infrared light offers a well-rounded treatment for your animal.
The way light therapy stimulates cells can help treat several conditions in animals, including:
Clinical data has supported and proven light therapy’s effectiveness in treating animals. In one study, horses suffering from chronic back pain responded to red light therapy in less than three months of therapy, with 70% gaining the ability to train and compete. Other studies have also proven that horses treated with red light therapy experience faster tissue healing times.
If you’re considering treating your dog or cat with light therapy, the first thing you need to do is consult your veterinarian, ensuring it’s the right treatment option for your pet.
Light therapy treats various conditions; however, if your pet is experiencing severe SAD, they may need an extensive treatment plan. At Kayian Medical, we love our animals and want to provide them with the best support possible.
Low-Intensity Light Therapy: Exploring the Role of Redox Mechanisms. Joseph Tafur, M.D. and Paul J. Mills, Ph.D.
Effect of NASA light-emitting diode irradiation on wound healing. J Clin Laser Med Surg. 2001
Treatment of chronic back pain in horses. Stimulation of acupuncture points with a low-powered infrared laser. Martin BB Jr. 1987.
Equine wound healing: influence of low-level laser therapy on an equine metacarpal wound healing model. Jann. 2012.
Effect of light-emitting diode (LED) therapy on the development of osteoarthritis (OA) in a rabbit model. Biomed Pharmacother. 2011
Low-level laser therapy reduces time to ambulation in dogs after hemilaminectomy: a preliminary study. Draper WE. 2012
The International Medical Device Regulators Forum (IMDRF) recognizes that a global approach to auditing and monitoring the manufacturing of medical devices could improve their safety and oversight on an international scale. At its inaugural meeting in Singapore in 2012, the IMDRF identified a workgroup to develop specific documents for advancing a Medical Device Single Audit Program (MDSAP).
What is MDSAP?
The Medical Device Single Audit Program (MDSAP) is a program that conducts a single regulatory audit of a medical device manufacturer’s quality management system that satisfies the requirements of multiple regulatory jurisdictions.
Why was the MDSAP developed?
The MDSAP was developed to enable appropriate regulatory oversight of medical device manufacturers’ quality management systems. The idea is to promote more efficient and flexible use of regulatory resources through work-sharing and mutual acceptance among regulators while respecting the sovereignty of each authority. Also, in the longer term, promote greater alignment of regulatory approaches and technical requirements based on international standards and best practices
Which Regulatory Authorities are part of the MDSAP?
The MDSAP was developed by representatives of the Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, MHLW/PMDA, and the U.S. Food and Drug Administration (FDA). All regulatory authorities participating in the MDSAP are equal partners in the program.
Which manufacturers are eligible for an MDSAP audit?
Any manufacturer of medical devices is eligible. However, each regulatory authority may establish exclusion criteria for some manufacturers. It is important to note that manufacturers that participate in the MDSAP program are responsible for securing and maintaining a contract with an MDSAP recognized auditing organization. In other words, medical device manufacturers are responsible for paying for MDSAP audits conducted by an auditing organization.
Does the MDSAP add requirements for the manufacturer?
No. The MDSAP audit model was developed to cover existing requirements from the Regulatory Authorities participating in the MDSAP. The program does not add any new requirements to existing requirements from ISO 13485.
What are the potential benefits?
What are the costs associated with MDSAP audits
The cost of conducting an MDSAP audit is dictated by the commercial arrangement between the medical device manufacturer and the authorized MDSAP auditing organization.
COVID-19 Remote Audits
The spread of Covid-19 globally has resulted in the imposition of quarantine orders and travel restrictions that are affecting the ability of auditing organizations to perform MDSAP audits.
On-site audits can only be substituted with remote audits where travel restrictions or social/physical distancing as a result of the pandemic prevent on-site audits from occurring.
In Kaiyan medical, we believe in the benefits of light. We believe in healing without chemicals. With our lights, we want you to have the best version of yourself. More at kaiyanmedical.com
For more detailed information about MDSAP please take a look at their documentation.
Useful links:
Like any other organ or part of the human body, the brain, too, is susceptible to injuries or declining functions, especially as we grow older. A healthy diet, physical exercise, and improving your blood pressure, blood sugar, or blood cholesterol levels are some of the ways through which you can maintain a healthier, younger brain.
The brain can suffer from numerous disorders that can be divided into:
Mentally stimulating activities are vital to keeping the brain young. Different brain activities, such as solving puzzles, math problems, or anything that may require at least some cognitive effort, contributes to the maintenance of the brain’s neural plasticity.
Neural plasticity is the ability of the central nervous system (CNS) to adapt to changes in the environment, aging, trauma, or injuries. It’s an important brain process in which neural networks work together to build a more resilient nervous system and maintain its proper functioning.
The first placebo-controlled study to demonstrate some of the benefits of Light Therapy treatments on the human brain was performed in 2013. Multiple improvements were observed among participants who received Light Therapy compared to the placebo group. Light therapy participants experienced:
In a more recent study effort, researchers treated older adults who were at risk of cognitive decline with Light Therapy. A positive neurocognitive effect was observed among the participants in this study, all of whom aged between 49 and 90. Some of the participants also struggled with cognitive decline due to vascular disease, however, Light Therapy was effective regardless of the nature of their cognitive decline.
As Light Therapy helped the elderly participants boost cognitive scores, researchers on the team were also able to observe their increased brain waves power (alpha, beta, and gamma brain waves in their resting state).
Combating age-related cognitive decline with Light Therapy has been in the focus of another recent study, published in February 2019. This study examined the frontal brain functions among elderly men. Frontal brain functions are key to directing behavior. The participants were divided into two groups, treatment, and placebo. Those who received treatment indeed showed improved cognitive performance following the treatment. These results demonstrate that Light Therapy can really work in a safe manner to treat age-related cognitive decline.
As of 2017, we also know that Light Therapy can improve the brain’s executive function. This is your ability to manage time, pay attention, change focus, plan, organize, multitask, remember details, or avoid saying the wrong thing at the wrong time3. In other words, the ability to create and meet goals.
As research further suggests, Light Therapy helped study participants to better perform in the Wisconsin Card Sorting Task (WCST)4. This is a neurophysiological test where the task-takers are asked to match a set of cards presented to them, in an attempt to assess their ability to demonstrate cognitive flexibility–a key process in cognitive ability. They are not told how to match the cards, but only if their particular match is correct or not. The WCST is a clinical way to measure the brain’s executive function. Those participants who received Light Therapy made fewer errors on the task and demonstrated improved set-shifting ability compared to the control group.
Such results suggest that Light Therapy improves the brain’s executive function and may have intriguing potentials for treating or preventing deficits resulting both from aging or neuropsychological disorders which include conditions such as epilepsy, stroke, migraines, brain tumors, dementia, multiple sclerosis, Parkinson’s and Alzheimer’s among others.
In 2017, scientists tested 118 people to see if Light Therapy can have a meaningful impact on their learning abilities. In a similar fashion to previous research, the participants were divided into treatment and placebo groups. Light Therapy showed that the treatment group improved their learning capabilities.
During the trial, the Light Therapy device was directed at the lateral prefrontal cortex of participants, and following treatments, they experienced faster and better rule-based learning5. So, imagine having all participants been bartenders demanded to know the exact ingredients of Mojito, Bloody Mary, Margarita, and other essential cocktails. This Light Therapy treatment would have aided their ability to remember all the ingredients needed for fashioning each drink, adding each ingredient in the desired sequence, or remember who on the table ordered a stronger Bloody Mary. We demonstrate this type of ability through our brain’s rule-based learning capacity.
Different life events may inhibit our brain’s ability to learn. Aging certainly is one of them. Other reasons may include extended exposures to pesticides or neurotoxins, which impair the mitochondria in brain cells. Since Light Therapy kind of “exercises” the mitochondria and prompts the brain to forge new neural networks, the process itself acts as a cognitive rehabilitation6. Which also leads us to the next section.
Cognitive decline may occur due to traumatic brain injuries, too. A person who suffers from one may face memory or concentration problems, mood swings, depression, anxiety, or speech problems among other TBI manifestations. What gives hope is another batch of studies that attests to the positive cognitive benefits among TBI patients from receiving Light Therapy.
Light Therapy has been shown to stimulate the growth of new nerve tissue and synapses in damaged brain cells, thus improving the cognitive brain functions of those patients who not only suffer from TBI but also from Chronic traumatic encephalopathy (CTE). The latter is a degenerative brain disease prevalent among athletes and military veterans or anyone who presents with a history of repetitive brain trauma.
https://www.webmd.com/add-adhd/executive-function#1
https://www.sciencedaily.com/releases/2015/04/150402161648.htm
https://www.cambridgecognition.com/cantab/cognitive-tests/memory/delayed-matching-to-sample-dms/
https://www.health.harvard.edu/mind-and-mood/12-ways-to-keep-your-brain-young
https://en.wikipedia.org/wiki/Psychomotor_vigilance_task
https://www.radiologyinfo.org/en/info.cfm?pg=carotid-intima
https://www.mayoclinic.org/diseases-conditions/traumatic-brain-injury/symptoms-causes/syc-20378557
https://brainworksneurotherapy.com/what-are-brainwaves
https://concussionfoundation.org/CTE-resources/what-is-CT
https://en.wikipedia.org/wiki/Wisconsin_Card_Sorting_Test.
