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It’s common knowledge that as we age, our normal brain function gets disrupted. We tend to find it harder to recall information, memorize names, and respond with reason. The decline of our mental acuity causes these commonplace mental problems. Contrary to popular belief, aging is not the sole culprit for mental deterioration. Many factors, such as aging, lifestyle changes, and environmental stress, contribute to the decline of mental acuity.
As cognitive decline progresses, significant mental changes can result in disorders such as dementia, Alzheimer’s disease, and Parkinson’s disease. While these can be common aspects of life, they aren’t inevitable. Many medical experts believe that there are many lifestyle changes that you can take to prevent the degradation of Mental Acuity.
What is Mental Acuity?
Mental acuity is known as the sharpness of the mind. It involves our cognitive ability to concentrate, process, understand, reason, and memorize. On the other hand, intelligence means the extent to which our brains absorb and process a specific amount of information at a given amount of time. Mental acuity is a natural and essential aspect of our brain health and is not a measure of how “smart” we are.
Mental acuity allows us to perform daily activities effectively and efficiently. When our cognitive ability functions well, we’re more capable of doing things without damage or conflict.
What are the symptoms of a Deteriorating Mental Acuity?
Some signs of a deteriorating cognitive ability may be subtle. However, when left untreated could progress over time to more serious mental disorders. According to the National Institute on Aging, 8 out of 10 people who experience amnestic mild cognitive impairment develop into having Alzheimer’s disease.
Here are some early symptoms of a deteriorating mental acuity:
How to Improve Mental Acuity
Prevention is better than cure when it comes to developing chronic brain disorders. Here’s how you can take your brain health into your own hands by observing these lifestyle habits:
Getting enough nutrition is the key to ensure mental sharpness. Making sure you eat a well-balanced diet can help your body supply enough nutrients to your brain. Omega 3 Fatty Acids are essential nutrients that help build and restore brain cells. The brain also needs antioxidants to prevent inflammation.
Excessive intake of toxins such as alcohol and drug can depreciate your mental ability. Experts agree that poor gut health also results in a weakened immune system. As a result, it weakens your body’s inflammatory response. A poor inflammatory response causes mental disorders such as schizophrenia and dementia.
Irregular sleep patterns and sleep deprivation disrupt your body’s circadian rhythm that can lead to short-term mental problems as well as long-term chronic health problems.
Your body’s circadian rhythm is a natural body clock that controls your sleep-wake schedule as well as your digestive patterns. When you’re sleep-deprived, these rhythms get disturbed. As a result, you experience headaches, mood swings, and difficulty to focus and recall information. Aside from these unwanted effects, not having enough sleep also negatively impacts your overall brain health.
Exercise isn’t just for physical and aesthetic purposes. It also affects brain function in multiple ways. When you exercise, your body pumps more oxygen into your brain through an increased heart rate. Exercise allows your body to release hormones that are vital in nourishing your brain cells. It also promotes growth factors in your brain to assist in the growth of neuronal connections.
A study at the University of Georgia shows that a 20-minute exercise daily can improve memory retention and information processing. Many experts agree that a sedentary lifestyle may accelerate your way into cognitive decline.
Red Light therapy is a more modern approach to non-invasive and low-risk medical treatments. It is a form of photobiomodulation that allows light to change human cells' physiology that causes a wide range of benefits such as biological balance and cellular energy.
Kaiyan Medical is one of the pioneers of Red light therapy that uses red wavelengths to deliver benefits to the skin and near-infrared lights to penetrate deeper within the skin’s surface. This dual technology allows for better absorption and effectiveness of the benefits of Red light therapy.
As near-infrared wavelengths penetrate the brain’s cellular system, it promotes energy production by stimulating the mitochondria. It also prevents stress by keeping away oxidative stress. Thus, it delivers multiple benefits such as better blood flow, faster cell regeneration, and improved healing.
A study shows that red light therapy has significantly improved brain function when given to patients with cognitive dysfunction. All these benefits are vital in promoting and maintaining a healthy mental acuity. Red light therapy delivers all these cellular benefits to promote better sleep quality and a more balanced circadian clock.
As you maintain these lifestyle changes, you can experience a more improved brain function and better brain health. Now you can defy all odds and allow your brain to perform at its peak by having a healthy lifestyle and a balanced body.
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Biohacking is the practice of changing our chemistry and our physiology through science and self-experimentation to energize and enhance the body. It’s a broad definition, but that’s also because the concept is constantly evolving. It includes implementing lifestyle and dietary changes that improve the functioning of your body, as well as wearable technology to help you monitor and regulate physiological data. It can even run to extremes such as using implant technology and genetic engineering.
The possibilities are endless, but they are all rooted in the idea that we can change our bodies and our brains, and that by doing so we can ultimately become smarter, faster, and better as human beings.
Start biohacking your body by using wearables like the FitBit or the Apple Watch to track the way you operate. You could also start experimenting with the power of music in your everyday life and adopting a sustainable healthy diet. But if you’re ready for something new, and something different, consider one of these non-invasive methods from our biohacking guide:
Have you ever spent a lot of time indoors and begun to feel… off? Our bodies and brains need light to function at their best. Not only does the sun give us an important dose of vitamin D, but it helps us in a number of other physiological and emotional ways. Let’s look a little closer – specifically at the light wavelengths between 600 and 900 nanometers (nm). How does this range of light waves impact us and how can we use it to biohack the body?
Studies have shown that your body responds particularly well to red and near-infrared wavelengths, which range from 600 to 900 nm. This particular range of light waves is absorbed by the skin to a depth of about 8 to 10 millimeters, at which point your mitochondrial chromophores absorb the photons. This activates a number of the nervous system and metabolic processes.
In plainer terms, red light therapy has become an increasingly popular form of biohacking used to treat a number of conditions. It has been proven to relieve pain, reduce inflammation, and restore mood. And because it is a non-invasive and non-chemical treatment, it’s not as intimidating as other forms of biohacking.
With over 100 billion neurons that are constantly using electricity to talk to each other, your brain is like Grand Central Station. If everyone is chattering loudly at the same time, it can be tough to concentrate on what you need to get done. That’s where music biohacking comes in. Brain activity can be measured in a wave-like pattern and determines if you feel alert, sleepy, relaxed, or stressed. Things that can affect your brainwaves include the activity you are currently performing, how much restorative rest you’ve had, and what you’ve just eaten or drank.
One of the most reliable ways to change your brainwaves is through a consistent sound wave. Audio entrainment, a form of music biohacking, uses binaural beats and tones to synchronize with your brain waves and induce a meditative, relaxed state. You can access programs developed specifically for your own brain and the activities you want to accomplish at Brain.fm. If you’re not ready to go that far, you can still change your mood and mindset by queuing up your favorite playlist and listening while you work out, cook breakfast, or commute to work.
We talk a lot about cardiac health. After all, heart disease is the #1 killer of women in the United States. Everyone needs to be aware of cardiovascular diseases and how to protect themselves as best they can. As a culture, we also talk a lot about skin health – slathering on sunscreen as part of our daily routine and supplementing our diets with collagen-boosting foods. Weight loss, inflammation, memory, GI health, and how an unhealthy diet and lack of exercise can prematurely age you – these are all at the forefront of our minds. But how often do we think about the health of our bones?
A decrease in bone health creeps up on you and most people are unaware of how bone density changes over time. Roughly up until the age of 30, men and women actually build more bone than they lose, so we are constantly strengthening our bones and working on bone density. But when we hit our mid-30s, things change. And if you’ve passed that benchmark, you may have felt that shift.
After reaching their mid-30s, women lose about 2% of bone density every year, and that continues for a few years following menopause. This leaves women with a high likelihood of experiencing osteoporosis.
So what do you do? Consider trying OsteoStrong, a non-pharmaceutical way of improving bone density, strength, and balance as one of your biohacking techniques.
According to OsteoStrong’s website, research indicates that the stimulus required to activate the growth of healthy bone tissue is 4.2 multiples of body weight. However, this level of force would be exceptionally difficult to achieve on your own. That’s why OsteoStrong utilizes the Spectrum System, which is part of a new category of devices called the Robotic Musculoskeletal Development System (RDMS).
How we view life has a huge effect on our moods, how we treat others, and our general levels of fulfillment. When you have an abundance mindset, you’re consistently grateful for everything that comes your way and is always focused on the positive. Have a hard time adopting this type of perspective? Changing your mindset is really about nothing more than practice. You need to consistently refocus your brain to see the positive in every situation until it becomes second nature. These biohacking techniques and tools can help:
Exercising, eating right, and developing the right mindset are important steps to unlocking an extraordinary life. Biohacking helps you take this to the next level by incorporating supplements that improve focus, increase energy, and help your body benefit from the most bioavailable forms of nutrients available.
We often don’t get all the vitamins and minerals we need to keep us at peak performance. High-quality supplements in the form of pills, shakes, bars, or drinks can fill the nutritional gap and help boost performance, detoxify our systems, and achieve daily energy.
Tony has created a variety of health supplements, drinks, and bars that help you feel your best every day and make biohacking the body easy.
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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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:
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.
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.
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.
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, 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.
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.
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.
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.
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.
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) 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, 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.
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).
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.
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.
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, 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, 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, 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.
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.
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.
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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, 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.
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).
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 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.
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.
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, 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, 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, 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.
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, 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.
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 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 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, 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.
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, 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.
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.
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 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 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 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.
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, 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, 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.
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, 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.
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, 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.
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.
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, 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, 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.
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.
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, 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, 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.
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, 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, 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, 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, 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, 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.
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.
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.
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.
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.
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, 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, 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, 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, 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, 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.
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, 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.
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.
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, 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, 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, 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, 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.
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, 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.
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, 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, 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.
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, 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.
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
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.
