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Wednesday, September 30, 2020
Apple Watch's abnormal pulse feature driving many unnecessary healthcare visits, Mayo Clinic researchers say |
Friday, September 18, 2020
FDA-approved medical devices and algorithms: an online database | Digital Medicine
The 2010s has brought a rise in the number of studies and papers discussing the role of artificial intelligence (AI) and machine learning (ML) in medicine and healthcare (AI/ML). The number of life science papers describing AI/ML rose from 596 in 2010 to 12,422 in 2019. While we are at the beginning of the AI/ML era, the expectations are high and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions1.
Indeed, AI/ML-based technologies have been shown to support several medical specialties from radiology2 and oncology3 to ophthalmology4 and general medical decision-making5. ML models have been shown to reduce waiting times6; improve medication adherence7; customize insulin dosages8; or help interpret magnetic resonance images9, among others. AI/ML- based technologies are coming to electronic health record systems and AI based notifications and messaging systems.
We classify technology like AI/ML-based if official FDA announcements, communications by the company or other publicly available information resources used the expressions ‘deep learning,’ ‘machine learning,’ ‘deep neural networks,’ ‘artificial intelligence,’ and/or ‘AI’ to describe the technology11. For simplicity, we use the term “AI/ML-based” to denote these technologies in this paper. With the increasing expertise and attention on AI/ML in the medical field, the opportunities and possible implications of its use are the topics of an ongoing debate12. A crucial element in this implementation debate is regulating such technologies.Because of the high-risk nature of these medical devices and the unknown consequences of using AI/ML for medical decision-making and data analysis, the FDA has stringent regulatory requirements for medical device licensing. Developers of AI/ML-based medical devices and algorithms have to go through rigorous processes that are time and resource consuming. This can be considered pivotal as a barrier for the introduction of AI/ML in medicine.
Before medical hardware or software is legally made available in the US market, the parent company has to submit it to the FDA for evaluation. For medically oriented AI/ML-based algorithms, the regulatory body has three levels of clearance, namely, 510(k)14, premarket approval15, and the de novo pathway16, each of which needs specific criteria to be fulfilled in order to be granted (Table 1). This process is similar to drug approvals.
Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.
From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
Level of FDA clearance Description
510(k) clearance A 510(k) clearance for an algorithm is granted when it has been shown to be at least as safe and effective as another similar, legally marketed algorithm. The submitter seeking this clearance must provide substantial proof of equivalence in their application. Without approval of being substantially equivalent to the other algorithm, the one pending approval cannot be legally marketed.
Premarket approval Premarket approval is issued to algorithms for Class III medical devices. The latter are those that can have a large impact on human health and as such, their evaluation undergoes more thorough scientific and regulatory processes to determine their safety and effectiveness. In order to approve an application, the FDA determines that the device’s safety and effectiveness is supported by satisfactory scientific evidence. Upon approval, the applicant can proceed with marketing the product. de novo pathway Regarding the de novo classification, it is used to classify those novel medical devices for which there are no legally marketed counterparts, but which offer adequate safety and effectiveness with general controls. The FDA performs a risk-based assessment of the device in question before approval and allowing the device to be marketed.
Table 1 Descriptions of the types of FDA approvals for AI/ML-based medical technologies.
From: The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database
Monday, September 14, 2020
Stressors Take Toll on Students’ Mental Health -
Students will learn at their own pace. Some students will jump ahead, while some will lag behind, in much the same was in a normal school.
We also need to consider the teacher's needs and responsibilities. Teachers will not have physical responsibility for student safety. Social interaction and disruptive behavior will be lessened. Along with the technical challenges of video conferencing, new techniques will be learned. The new 'normalcy' will also prepare students for the new workplace of remote work.
As many predicted Covid 19 has transformed our lives, at work, at home, and in education.
Distance learning may not be appropriate for early elementary school where physical presence is important for developmental socialization.
Surveys of parents with school-age children reveal the mental health challenges faced by their young ones. A Gallup poll conducted in May found that among parents with children in kindergarten through grade 12, 29% said their child was “already experiencing harm” to their emotional or mental health because of physical distancing and pandemic-related closures of schools and businesses.
Tuesday, September 8, 2020
The Future Of Prosthetics Depends On A.I
Back in 2011, archeologists unearthed one of the oldest known prosthetic devices; a wooden toe buried with Egyptian mummies some 3,000 years ago. While aesthetically it packs a steampunk look, this artificial toe was far from being a cosmetic item. After testing replicas, researchers found that they were indeed practical devices that helped in walking. While throughout the millennia the materials have changed, prosthetics only evolved in recent decades with the advent of robotic prostheses.
Advance forward 5-6 millennia
From steampunk Egyptian mummies to cyberpunk brain-controlled prosthetics
The technology is already here including material sciences, electronic, microchips, sensor technology, and human innovation, curiosity and goals.
The necessary steps to develop a self-sustaining business include already well-known startup implementation, venture capital funding, and committed leaders. The future prosthetic industry will require large amounts of capital which may include private, venture capital funding as well as existing companies in this field. A critical issue will be market demands and health payer reimbursements. Payer challenges may be met by different market segments. Military and Veterans Benefits will be the first to source this capability as many amputations result from battle. It would seem the government will invest in R&D for prosthetics just as it has for military robotics, which includes augmented skeletons for load-carrying heavy supplies, as well as robotic mules.
The future has arrived. Want proof? Check out these amazing robotic exoskeletons
The Future Of Prosthetics Depends On A.I. | LinkedIn
Friday, September 4, 2020
Common class of drugs linked to onset of Alzheimer’s – Scientific Inquirer
As we age more and more people develop Alzheimer's disease. This form of dementia is a specific one with 'tangles' and tau proteins infiltrating parts of the brain. It is only one form of dementia.
Given the growing number of aged people and increasing life span, Alzheimer's Disorder has become a public health problem. People with Alzheimer's disease do not usually die from it and are victim to other disorders of aging, heart disease, hypertension, cancer, or kidney disease. Sadly it robs them, family and friends of a loved one.
Researchers have searched for a "cause" suspecting toxins, drugs, environmental and immune disorders. Alzheimer's disorder seems to have become more prevalent in a time when patients are subject to the use of many more drugs. Could this be a factor in Alzheimer's Disorder?
A team of scientists, led by researchers at the University of California San Diego School of Medicine, report that a class of drugs used for a broad array of conditions, from allergies and colds to hypertension and urinary incontinence, may be associated with an increased risk of cognitive decline, particularly in older adults at greater risk for Alzheimer’s disease (AD)
The study done at the University of California San Diego is published in Neurology found that patients taking anticholernigic drugs (AD) and who had genetic markers for AD were four times more likely to develop MCI (mild cognitive impairment) a term which is inclusive of AD)
Anticholinergics can treat a variety of conditions, including:
Urinary incontinence, overactive bladder (OAB), chronic obstructive pulmonary disorder (COPD), certain types of poisoning
They also help block involuntary muscle movements associated with certain diseases such as Parkinson’s disease. Sometimes, they’re used before surgery to help maintain body functions while a person is treated with anesthesia.
List of anticholinergics
Anticholinergics are only available with a doctor’s prescription. Examples of these drugs include:
atropine (Atropine)
belladonna alkaloids
benztropine mesylate (Cogentin)
aclidinium
cyclopentolate (Cyclogyl)
darifenacin (Enablex)
dicyclomine
fesoterodine (Toviaz)
flavoxate (Urispas)
glycopyrrolate
homatropine hydrobromide
hyoscyamine (Levsinex)
ipratropium (Atrovent)
orphenadrine
oxybutynin (Ditropan XL)
propantheline (Pro-banthine)
scopolamine
methscopolamine
solifenacin (VESIcare)
tiotropium (Spiriva)
tolterodine (Detrol)
trihexyphenidyl
trospium
To add to this list we must also include certain other drug classes that are used for other purposes and have anticholernigic properties, such as Benadryl (diphenhydramine (commonly used for allergy.
Many of these drugs are used and coexist with patients with Alzheimer's disorder. Add to this as we age are metabolic changes. Dosage may be a factor for elderly patients. Doses should be adjusted appropriately.
There is conflicting information regarding the role of tau proteins, neurofibrillary tangle in AD. Are they cause, or effect?
Some information examines the role of gum disease, specifically the presence of the bacterium, p.gingivales.
There are many confounding factors for investigators to tease out in their search for a cause.
Common class of drugs linked to onset of Alzheimer’s – Scientific Inquirer
Tuesday, September 1, 2020
COVID-19 Vaccine Research Is Facing a Monkey Shortage - The Atlantic
As COVID-19 vaccine development has moved forward at an unprecedented pace, though, some pharmaceutical companies have started human trials before monkey studies have concluded. And with monkeys so hard to come by, others are wondering if certain studies can be skipped altogether. Linda Marbán, the CEO of the biotech company Capricor Therapeutics, says her company originally tried to test its vaccine candidates at the California primate center. It couldn’t get in. She’s now exploring how to go straight into human-safety trials.
Scientists who work with primates, however, say that the animal research still offers certain advantages. Monkeys can be challenged—that is, deliberately infected with COVID-19 after being given an experimental vaccine. Researchers can then follow the animals’ exact progression of disease or lack thereof, tracking how quickly antibody levels shoot up or whether a vaccine reduces how long the monkey sheds the virus. These details are harder to get in human trials because people are naturally exposed to COVID-19 and aren’t being monitored every day. (Although some researchers have proposed human challenge trials for COVID-19, the idea is controversial and none has begun.)
Simians are used because they are also considered primates, the same family that human beings are a member. The close genetic relationship sometimes allow researcher to test medications prior to actual human trials.
The relative scarcity of these monkeys is also due to activism several decades ago. PETA and other animal rights groups invaded and destroyed hundreds of monkeys by breaking into laboratories and destroying them. This provoked national attention to the plight of research animals. Many ongoing research studies were destroyed, cancelled or terminated outright. No one can argue with humane treatment of animals during test studies.
PETA today remains quite active with celebrities advocating kindness to animals. These activities draw quite a bit of interest. Many of their claims are half-truths and accusations of NIH being cruel to animals is untrue, bordering on libel.
Following the PETA protests in the 1980s Congress, the FDA and NIH reviewed their practices. and established new regulations.
The animals were bred in companies specifically tasked with breeding monkeys, mice (some) are genetically modified for specific diseases. Knock-out mice have been in use for several decades and are instrumental in treating, studying and modeling different kinds of cancer, obesity, heart disease, diabetes, arthritis, substance abuse, anxiety, aging and Parkinson disease.
Regulation and inspection by Animal Abuse Abundant in Spite of AAALAC Accreditation - USDA Data reveals repeated citations of animal laboratories.
Both sides have self-interest involved. Research laboratories and
-19 Vaccine Research Is Facing a Monkey Shortage - The Atlantic
Sunday, August 30, 2020
Introducing Rare Diseases- Optime Care- Find your Medications
Another term is "small patient communities". There are internet sources that help you and your caregiver community in treating you.
A rare disease is generally considered to be a disease that affects fewer than 200,000 people in the United States at any given time. There are more than 6,800 rare diseases. Altogether, rare diseases affect an estimated 25 million to 30 million Americans.
NORD is a central source of information for patients and providers.
The topmost common small patient communities:
- Morgellons. ...
- Progeria. ...
- Water allergy,"aquagenic urticaria" ...Yes, there is such a thing...only 30 cases have been reported
- Foreign accent syndrome. ...
- Laughing Death. ...
- Fibrodysplasia ossificans progressiva (FOP) ...
- Alice in Wonderland syndrome. Strange things happen when you have an episode of AIWS
- Your body parts or things around you may look bigger, smaller, closer, or farther away than they really are.
- Straight lines may look wavy.
- Things that are still may seem to move.
- Three-dimensional objects may look flat.
- Things may change colors or tilt to the side.
- Faces may look distorted.
- Colors may look extra bright.
- People and objects may look stretched out.
- Doctors aren't sure why some people have these unusual changes in perception. But it often starts when children are very young.
- AIWS involves changes to parts of your brain that deal with sensory information -- what you see and hear. These changes affect how you see your own body and its relation to the world around you.
- Doctors believe AIWS might be a type of migraine aura. Auras are visual and other sensory problems some people get before or during a headache. They can cause things like flashing lights, shimmering spots, ringing in your ears, or a tingling in your hands.
- AIWS often happens before, during, or after a migraine. But it also can happen with these other conditions:
Introducing Rare Voices - Optime Care
Friday, August 28, 2020
Lawmakers cleared the way for telemedicine, but seniors need access, training
Technology and lack of broadband are holding back some seniors.
Monica Stynchula, a member of the Florida Telehealth Advisory Council and founder of ReunionCare, a digital platform for managing seniors’ care, said the biggest barrier to telemedicine is lack of universal broadband access.
The Trump administration has loosened restrictions on insurance coverage for telemedicine so doctors’ offices are able to bill for virtual appointments just as they do for office appointments. But some patient advocates worry that barriers still remain for seniors, one of the populations most vulnerable to COVID-19.
“When we talk about frailty and looking at muscle function, you know, how many chair stands can you do? Well, suddenly, if you have an iPad, you could set that iPad down and you could watch on video, this older adult stand up and sit down unaided, repeatedly, and you could do some of these functional tests and witness them in real time,” she said. “You can’t do that on the phone.”
The process requires an intermediary, someone on site who sets up the calls.
There are intermediaries that also fulfill this function, independently or part of a portal, health information exchange, such as Reunion Care.
Lawmakers cleared the way for telemedicine, but seniors need access, training
Tuesday, August 25, 2020
First Person to Be Reinfected with COVID-19 Recorded in Hong Kong
In many ways Coronavirus acts like most viruses. It's the mechanism of action however is quite different from an ordinary "respiratory virus'. It is not a true respiratory virus although it has been channeled into the 'influenza' family.
First proven case of reinfection
Hong Kong scientists observing the patient in question have noted that the two strains of the virus are different.
The report on the matter, written by Hong Kong University scientists and shared on Twitter, explained how the man in his thirties spent 14 days in hospital when he was first diagnosed with COVID-19 where he recovered. Following this, during a screening at the airport, he tested positive once again for the virus, despite being asymptomatic.
Sunday, August 23, 2020
Stroking Out While Black—The Complex Role of Racism | Cerebrovascular Disease | JAMA Neurology | JAMA Network
Just this week the JAMA Neurology published an academic article about "Stroking Out While Black-The Complex Role of Racism."
The killing of George Floyd, an unarmed 46-year-old Black man by a White police officer in Minneapolis, led to widespread protests against police brutality. Beginning with a focus on law enforcement reforms, the protests grew in diversity and objective, evolving into a broader call to end institutionalized racism. For the first time in history, a diverse, global coalition came together to protest injustice in the societal treatment of Black lives. Perhaps it was the collision of George Floyd’s horrific death with the disproportionate and egregiously high death rates and coronavirus disease 2019 infection rates within communities of color in the US that fueled this movement. Of note, precursors of change, such as the diversity, inclusion, and equity initiatives being spawned in all major sectors (economic, education, health), hold out hope for meaningful progress. This Viewpoint highlights the complex role of racism in stroke and suggests a framework for understanding its effects.
The same may be said for the systemic disparity in health care for people of color, African American, Latino, and Native Americans. Each group has its own issues regarding health and wellness.
Native Americans in particular are isolated often in remote areas with a paucity of health institutions, although served by the Indian Health Service. The incidence of infectious disease, chronic illness, especially diabetes, obesity, and hypertension is much higher than in white populations.