Posts Tagged ‘Food and Drug Administration’
First, do no harm? Six reasons to approach anti-amyloid drug Aduhelm cautiously, if at all
6 ways the FDA’s approval of Aduhelm does more harm than good (STAT News): Like many people, I was shocked when the Food and Drug Administration ignored the advice of its neurological drugs advisory panel and broadly approved Biogen’s new drug, Aduhelm, even for populations never included in the clinical trials to assess the drug.
Read MoreFDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation
FDA Releases Artificial Intelligence/Machine Learning Action Plan (FDA press release): Today, the U.S. Food and Drug Administration released the agency’s first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. This action plan describes a multi-pronged approach to advance the Agency’s oversight of AI/ML-based medical software … The AI/ML-Based Software as a…
Read MoreQuestionable “Alzheimer’s blood test” goes on sale prior to FDA approval
First blood test to help diagnose Alzheimer’s goes on sale (NBC News): A company has started selling the first blood test to help diagnose Alzheimer’s disease, a leap for the field that could make it much easier for people to learn whether they have dementia. It also raises concern about the accuracy and impact of such…
Read MorePortable 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…
Read MoreBrain hacking emerges as latest trend in wearable tech, but is it ready for prime time?
———- Brain-zapping gadgets promise to make you a better you — smarter, stronger, even happier (The Washington Post): “Americans’ obsession with wellness is fueling a new category of consumer electronics, one that goes far beyond the ubiquitous Fitbits and UP activity wristbands that only passively monitor users’ physical activity. The latest wearable tech, to put it…
Read MoreNext: Is it a videogame, or an FDA-approved medical treatment?
. Play This Video Game and Call Me in the Morning (KQED): “The brain network that controls multitasking connects with networks that control memory and attention span. So by playing the game, some scientists believe you can improve cognitive skills, and by extension, relieve a range of symptoms associated with
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