FDA 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…

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Ohio Opioid Technology Challenge funds program testing neurofeedback-based brain training to reduce cravings and battle opioid addiction

_______ Bat­tling Addic­tion With Brain­pow­er (Uni­ver­si­ty of Day­ton press release): “The Uni­ver­si­ty of Day­ton Research Insti­tute has won a $10,000 Ohio Opi­oid Tech­nol­o­gy Chal­lenge award for a pro­gram that will teach peo­ple with opi­oid addic­tions how to reduce their crav­ings by regain­ing con­trol of their brains. “Using neu­ro­feed­back, we’ll work with our vol­un­teers to help…

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The FDA creates new Digital Health unit to reimagine regulatory paths in the age of scalable, AI-enhanced innovation

— Med­i­cine Is Going Dig­i­tal. The FDA Is Rac­ing to Catch Up (Wired): “WHEN BAKUL PATEL start­ed as a pol­i­cy advi­sor in the US Food and Drug Admin­is­tra­tion in 2008, he could pret­ty much pin­point when a prod­uct was going to land in front of the review­ers in his divi­sion. Back when med­ical devices were…

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Monitoring health, wellness and fitness via wearable devices: Key Neurotech Patent #29

Today we are shar­ing a fas­ci­nat­ing 2007 patent assigned to Body­media. (As men­tioned, we are fea­tur­ing a foun­da­tion­al Per­va­sive Neu­rotech patent a day, from old­er to new­er by issue date) U.S. Patent No. 7,261,690: Appa­ra­tus for mon­i­tor­ing health, well­ness and fit­ness. Assignee(s): Body­media, Inc. Inventor(s): Eric Teller, John M. Stivoric, Christo­pher D. Kasabach, Christo­pher D. Pacione, John L.…

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New $100M investment in Canada to accelerate brain health innovation

. Brain research at Toron­to health cen­tre gets $100M fund­ing boost in fed­er­al bud­get (Nation­al Post): “Ottawa is help­ing fund a $100 mil­lion ini­tia­tive with Toronto’s Bay­crest Health Sci­ences to devel­op a nation­al hub for brain research…“Past gen­er­a­tions of adults said they were most con­cerned about can­cer or heart dis­ease. This gen­er­a­tion says they’re most concerned…

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