A conversation at the frontier of digital health innovation, FDA regulations, and cognitive health

Dig­i­tal Ther­a­peu­tics for MCI and Alzheimer’s dis­ease: A Reg­u­la­to­ry Per­spec­tive (The Jour­nal of Pre­ven­tion of Alzheimer’s Dis­ease): –This arti­cle is adapt­ed from a com­pre­hen­sive con­ver­sa­tion between Dr. Murali Doraiswamy and Dr. Jef­frey Shuren at the 2021 Clin­i­cal Tri­als on Alzheimer’s Dis­ease (CTAD) con­fer­ence in Boston. Dr. Shuren is a behav­ioral neu­rol­o­gist who has held a variety…

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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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Digital health meets consumer electronics and brain training

There’s no doubt that the biggest buzz at this year’s Con­sumer Elec­tron­ics Show in Las Vegas didn’t come from the slimmest of tele­vi­sions, the most fash­ion­able head­phones or even a danc­ing robot. The buzz of CES 2013 was firm­ly cen­tred on all things health and the Dig­i­tal Health Sum­mit is where the action was hap­pen­ing. On…

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