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digital health innovation

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

March 23, 2022 by SharpBrains

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 of lead­er­ship roles at the FDA and CMS, includ­ing as Direc­tor of the Cen­ter for Devices and Radi­o­log­i­cal Health (CDRH).

MD: The CDRH has a flag­ship Dig­i­tal Health Cen­ter of Excel­lence. Can you tell us about it? And can you share your advice for how the Alzheimer’s field can help spur dig­i­tal inno­va­tion? [Read more…] about A con­ver­sa­tion at the fron­tier of dig­i­tal health inno­va­tion, FDA reg­u­la­tions, and cog­ni­tive health

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Alzheimer’s Disease, CDRH, cognitive-health, CTAD, digital health, Digital Health Center of Excellence, digital health innovation, Dr. Jeffrey Shuren, Dr. Murali Doraiswamy, FDA, innovation, MCI, precertification

FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

January 25, 2021 by SharpBrains

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 Med­ical Device Action Plan out­lines five actions that the FDA intends to take, including:

  • Fur­ther devel­op­ing the pro­posed reg­u­la­to­ry frame­work, includ­ing through issuance of draft guid­ance on a pre­de­ter­mined change con­trol plan (for software’s learn­ing over time);

[Read more…] about FDA releas­es first Arti­fi­cial Intel­li­gence (AI) reg­u­la­to­ry plan to pro­mote respon­si­ble dig­i­tal health innovation

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: artificial intelligence, digital health, digital health innovation, FDA, Food and Drug Administration, innovation, machine-learning, regulatory framework, software

Digital health meets consumer electronics and brain training

January 30, 2013 by Dr. Evian Gordon

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 the eve of open­ing Ari­an­na Huff­in­g­ton described what was about to hap­pen in Las Vegas as a ‘Per­fect Storm’

“I’m talk­ing about one of those moments in which sev­er­al trends con­verge to cre­ate some­thing larg­er, a moment we will look back on as the time every­thing changed ….. this year’s CES has the poten­tial to be one of the most trans­for­ma­tive ever, and that’s because of a sig­nif­i­cant change in atti­tude about what role tech­nol­o­gy can, and should, be play­ing in our lives. That’s the foun­da­tion of this per­fect storm”. [Read more…] about Dig­i­tal health meets con­sumer elec­tron­ics and brain training

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Arianna Huffington, behavior change, brain, brain habits, Brain-Fitness, Brain-health, Brain-Training, consumer electronics, Consumer Electronics Show, digital health, digital health innovation, digital health summit, GPS for the Soul, Hapifork, Muse, mybrainsolutions, resilience, Sanjay Gupta, smart person, Stress, train brain

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