The FDA ends precertification (Pre-Cert) pilot program, saying new authority required to regulate software as a medical device (SaMD)

FDA acknowl­edges short­com­ings of Pre-Cert pilot in report (Reg­u­la­to­ry Focus): The US Food and Drug Admin­is­tra­tion (FDA) said it needs addi­tion­al Con­gres­sion­al author­i­ty to move for­ward with its dig­i­tal health pre­cer­ti­fi­ca­tion (Pre-Cert) pro­gram. While the idea has been wide­ly laud­ed by var­i­ous stake­hold­ers, at least one expert said he feels vin­di­cat­ed for warn­ing the agency early…

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Update: Playing videogames may be more cognitively beneficial than other forms of screentime like social media, watching videos/ TV

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news and a fun brain teas­er to put your tem­po­ral lobes to good use :-) #1. Study finds that play­ing videogames may be more cog­ni­tive­ly ben­e­fi­cial for chil­dren than oth­er forms of screen­time (social media, watch­ing videos/ TV) “Here, we esti­mat­ed the impact…

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AI-enabled chatbot Wysa receives FDA Breakthrough Device designation for patients with chronic pain, depression and anxiety

AI Behav­ior Health Chat­bot App Fast-Tracked by FDA (Psy­chol­o­gy Today): Recent­ly the U.S. Food and Drug Admin­is­tra­tion (FDA) grant­ed break­through device des­ig­na­tion to Wysa’s AI-based dig­i­tal men­tal health con­ver­sa­tion­al agent that deliv­ers cog­ni­tive behav­ioral ther­a­py (CBT) via a smart­phone to adults suf­fer­ing from depres­sion, anx­i­ety, and chron­ic mus­cu­loskele­tal pain

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Digital therapeutics” vs. “Mental health apps”: A growing debate on standards, regulation and efficacy

The effi­ca­cy of Men­tal Health Apps (phar­mafo­rum): In Jan­u­ary, PLOS Dig­i­tal Health pub­lished a study which claimed that there’s “sparse” data to sup­port the effi­ca­cy of most men­tal health apps. In their meta-ana­ly­­sis of pub­lished stud­ies, the authors found uni­ver­sal defi­cien­cies and con­clud­ed that there’s no con­vinc­ing evi­dence that app-based inter­ven­tions deliv­er mean­ing­ful out­comes. Without…

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From “Eminence-based” to Evidence-based cognitive & mental healthcare: Time for quality and accountability

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news, two excel­lent new books and a few fun brain teasers. #1. From “Emi­­nence-based” to Evi­­dence-based men­tal health­care: Time to focus on qual­i­ty and account­abil­i­ty “The real chal­lenge is not find­ing a ther­a­pist, it’s find­ing a ther­a­pist who knows how to provide…

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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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