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FDA clears first videogame to be prescribed to kids with ADHD: EndeavorRx by Akili Interactive Labs
Screenshot of EndeavorRx In a landmark decision, FDA greenlights a video game for kids with ADHD (STAT): The Food and Drug Administration on Monday for the first time gave a green light to a game-based therapeutic: a video game meant to be prescribed to kids with ADHD. The game, known as EndeavorRx and developed by Boston-based Akili Interactive Labs, can now be marketed as a way to improve attention function in kids with ADHD as measured by computerized testing. Physicians can prescribe it to children between the ages of 8 and 12 who have an ADHD diagnosis and have demonstrated an issue with attention. The FDA’s move is...
Source: SharpBrains - June 18, 2020 Category: Neuroscience Authors: SharpBrains Tags: Cognitive Neuroscience Health & Wellness Professional Development Technology 510(k) Adam Gazzaley adhd Akili Interactive Labs computerized testing De Novo digital therapeutics EndeavorRx FDA game-based therapeutic TOVA videog Source Type: blogs

Reuse of a Small Molecule to Increase Autophagy in the Brain is Trialed for Alzheimer's Disease
Today I'll point out an example of drug reuse and autophagy upregulation. The processes of autophagy are responsible for recycling molecular waste and broken cellular structures. Autophagy is upregulated in response to stress placed upon cells, whether by heat, cold, lack of nutrients, a toxic local environment, and so forth. This is beneficial to tissue function, health, and longevity, and thus there is considerable interest in the research community in producing therapies that boost the operation of autophagy. This hasn't made a great deal of progress towards the clinic, but nonetheless in any of the sizable databases of...
Source: Fight Aging! - June 5, 2020 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs

STEM CELL THERAPY: Update on Patients Treated with PLX cells for Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19
On May 14, 2020, Pluristem Therapeutics Inc. published follow-up data on patients treated under their compassionate use program. These patients were all being treated for with Acute Respiratory Distress Syndrome (ARDS) associated with the SARS-CoV-2 virus, and in intensive care units requiring mechanical ventilation. As of the publication date, 18 patients have been treated with PLX cells, allogeneic mesenchymal-like cells derived from human placentas after the delivery of full-term healthy babies. The patients treated include one patient in the United States. This patient received the treatment as part of the FDA Single P...
Source: Cord Blood News - May 28, 2020 Category: Perinatology & Neonatology Authors: maze_cordadmin Tags: stem cells Source Type: blogs

Planning for Future Pandemics Including Smallpox Outbreaks: Interview with Dr. Phil Gomez, CEO, SIGA Technologies
The COVID-19 pandemic has had significant global consequences, with healthcare systems stretched to their limits, a growing death toll, and economic devastation as economies came grinding to a halt. The pandemic and its aftereffects will be with us for some time to come, but this isn’t the first pandemic humanity has weathered, and it won’t be the last. Given accelerating advances in medical technology, there is plenty to discuss in terms of how we can be better prepared for the next infectious disease event. While COVID-19 is widely thought to have arisen naturally through transmission between an animal and a hu...
Source: Medgadget - May 27, 2020 Category: Medical Devices Authors: Conn Hastings Tags: Exclusive Medicine Public Health Source Type: blogs

AI-Powered Teleradiology FDA Cleared for Triage in Departments Swamped by COVID-19: Interview with David Stavens, CEO of Nines
Nines, a teleradiology company based in Palo Alto, CA, recently received FDA clearance for their NinesAI medical device, which supports the automated radiological review of CT Head images for the possible presence of two time-critical, life-threatening indications: intracranial hemorrhage and mass effect. The technology can help radiologists in triaging cases. Nines is the first company to receive FDA clearance for AI technology that triages mass effect conditions. Teleradiology is an increasingly vital service for healthcare providers, whereby radiological images are sent to a radiologist in a remote location for analy...
Source: Medgadget - May 21, 2020 Category: Medical Devices Authors: Conn Hastings Tags: Exclusive Radiology Telemedicine Source Type: blogs

Adverse effects of hydroxychloroquine
In case you were ever stupid enough to follow Trump’s lead you would have already injected ultraviolets in your eyeballs by now to save you from Covid and maybe bathed in Domestos or sulfuric acid or both! Anyway, his latest bullshine claim is that he’s been taking the antimalarial drug hydroxychloroquine to keep Covid at bay. Well, for starters there is no evidence that this drug acts as a prophylactic against infection with SARS CoV-2 or indeed any pathogen other than the causative agent of otherwise drug-resistant malaria. It’s primary use is in treating lupus. There was some testing done weeks ago to...
Source: David Bradley Sciencebase - Songs, Snaps, Science - May 19, 2020 Category: Science Authors: David Bradley Tags: Health and Medicine Source Type: blogs

Portable brain assessment device by Headsafe secures 510(k) FDA clearance
__ FDA Clears Nurocheck, Portable Device to Quickly Assess Brain Health (MS News Today): “A portable device that can quickly measure electrical activity in the brain and relay it to doctors via a smartphone app, called the Nurochek system, has been cleared by the United States Food and Drug Administration (FDA) for use as a medical device. Its developer, Headsafe, plans to it soon make this brain assessment system available for use with patients in the U.S., ages 14 and older.” The Announcement: Headsafe Announces FDA Clearance and U.S. Launch of its NUROCHEK Portable Brain Assessment System (press release): “Headsaf...
Source: SharpBrains - May 14, 2020 Category: Neuroscience Authors: SharpBrains Tags: Cognitive Neuroscience Health & Wellness Technology 510(k) clearance app brain brain health technology brain-assessment EEG electrical activity FDA Food and Drug Administration Headsafe neurological testing Nurochek portable Source Type: blogs

U.S. Approves an At ‐Home COVID-19 Test—But Four States Ban It
Walter OlsonLast week I published a piece observing that precautionary government regulation often undercuts the resilience the system is able to show when confronted with a new peril or emergency. The example I gave came from the many rules adopted in response to the menace of terrorism after 9/11, which turned out to make it harder to react when an entirely different kind of emergency — the current pandemic — placed sudden new stresses on areas from airport logistics to a banking system asked to handle an unplanned surge of small business loan requests.Once you notice this pattern of regulati...
Source: Cato-at-liberty - April 22, 2020 Category: American Health Authors: Walter Olson Source Type: blogs

Maryland Acts in Support of the “Right to Test”
Jeffrey A. SingerThe Food and Drug Administration ’s cumbersome and ossified approval process for drugs and tests stands out as a major cause of the federal government ’s failure to quickly and effectively respond when the the COVID-19 virus first attacked. And one thing upon which all policymakers agree is that abundant testing —both for the presence of active infection and for evidence of previous infection and possible immunity—is crucial to ending this crisis.As I have writtenhere, on February 29 the FDA began to loosen these regulations, particularly regarding approval of tes...
Source: Cato-at-liberty - April 21, 2020 Category: American Health Authors: Jeffrey A. Singer Source Type: blogs

Can Artificial Intelligence effectively and ethically detect COVID-19?
Is Artificial Intelligence (AI) a viable solution to the COVID-19 testing crisis? This has been a major question buzzing in the minds of healthcare leaders as they scramble to come up with solutions to the short-supply of the conventional tests. Some researchers believe that it ’s possible to develop a specialized method to detect specific markers of the virus via AI. However, COVID-19-detecting algorithms are based on data from only dozens or hundreds of patients, whereas a fully effective and functional algorithm requires thousands of patient scans. Recently written algorithms were developed using scans of infected C...
Source: radRounds - April 19, 2020 Category: Radiology Authors: Julie Morse Source Type: blogs

COVID-19: Hidden Coinfections and Chain Reactions Parasitic Infectious Relationships within Us
By SIMON YU, MD, LT COL, USA (Ret) Dr. Tom Frieden, former director of the Centers for Disease Control and Prevention (CDC), opened up a new front in the Coronavirus War by saying we don’t just need to treat the acute disease, we need to treat the underlying conditions that make people more susceptible to serious disease progression. He focused on heart disease, and managing mitigating risk factors such as CVD, diabetes, hypertension and smoking in order to increase people’s odds for recovery. The initial focus has been pneumonia and acute respiratory distress syndrome (ARDS), with risk factors including asthma, chr...
Source: The Health Care Blog - April 15, 2020 Category: Consumer Health News Authors: Christina Liu Tags: COVID-19 CDC chronic disease holistic care Pandemic SDoH Source Type: blogs

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Margaret “Peggy” Hamburg, M.D., foreign secretary of the National Academy of Medicine and member of the Commonwealth Fund’s board of directors, served as commissioner of the Food and Drug Administration during the Obama administration. The Commonwealth Fund spoke to her about the challenges of developing and testing a safe and effective vaccine to protect against the novel coronavirus, as well what it would take to ensure the vaccine could be manufactured in the enormous quantities needed and distributed to meet public health and medical needs. (Source: The Commonwealth Fund: Blog)
Source: The Commonwealth Fund: Blog - April 14, 2020 Category: International Medicine & Public Health Authors: Sarah Klein, Martha Hostetter Source Type: blogs

Blood Filtering Device Wins FDA Emergency Use Authorization for COVID-19
The FDA has issued the first Emergency Use Authorization for a device to help treat COVID-19 patients currently in the ICU. Terumo BCT’s Spectra Optia Apheresis System, combined with Marker Therapeutics’ D2000 Adsorption Cartridge, is now indicated for adult patients with COVID-19 udergoing respiratory failure. The device is intended to lower the levels of cytokines and other proteins in blood that promote inflammation, hopefully thereby mitigating some of the terrible consequences of the infection. These can include shock, lung failure, other organ failure and result in death. “We thank the Food and Drug ...
Source: Medgadget - April 13, 2020 Category: Medical Devices Authors: Medgadget Editors Tags: Cardiology Critical Care Medicine News Public Health Source Type: blogs

Potential implications of testing an experimental mRNA-based vaccine during an emerging infectious disease pandemic
by Ariadne A. Nichol, B.S. Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna. The chief medical officer at Moderna, Dr. Tal Zaks, lauded the speed with which his company has provided a potential COVID-19 vaccine: “I think we’ve set a new record here.” However, the usual Food and Drug Administration (FDA) standard for proving safety and effic...
Source: blog.bioethics.net - April 10, 2020 Category: Medical Ethics Authors: Blog Editor Tags: Clinical Trials & Studies Featured Posts Public Health Research Ethics #covid19 #diaryofaplagueyear COVID-19 Source Type: blogs

How Germany Leveraged Digital Health to Combat COVID-19
If you take a look at the number of novel coronavirus cases, you will notice that Germany ranks among the top in terms of most cases. Now, if you take a closer look, you will see that the number of fatal cases in the country is merely a fraction of the total cases. Their mortality rate has been consistently lower than that of those nations sharing a similarly high number of confirmed cases like China, Italy and Spain. How does Germany manage those numbers? The truth is that even experts aren’t sure. “We don’t know the reason for the lower death rate,” Marieke Degen, deputy spokeswoman of Germany’s Robert Koch ...
Source: The Medical Futurist - April 9, 2020 Category: Information Technology Authors: Prans Tags: Future of Medicine Healthcare Policy digital health coronavirus covid covid19 germany Source Type: blogs