Brain Health in 2030: Navigating Neuroplasticity & the Digital Health Market

Brain Health in 2030: Nav­i­gat­ing Neu­ro­plas­tic­i­ty & the Dig­i­tal Health Mar­ket from Sharp­Brains Keynote deliv­ered by Álvaro Fer­nán­dez, CEO of Sharp­Brains, dur­ing cor­po­rate retreat. Key mes­sage: Our very human brains and minds are the most sophis­ti­cat­ed tech­nol­o­gy at our dis­pos­al, so we should invest more time learn­ing about how they work and har­ness­ing neu­ro­­plas­tic­i­­ty-based methods…

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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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On mental fitness beliefs, lifestyles and new tools like apps, digital therapeutics, virtual reality, “brain age gaps” and more

Wel­come to a new edi­tion of Sharp­Brains’ e‑newsletter, fea­tur­ing time­ly brain & men­tal health news and a fun cou­ple of math brain teasers. #1. Study on the “ABCs of Men­tal Health” finds that sim­ply believ­ing you can improve men­tal well­be­ing helps actu­al­ly improve it Beliefs mat­ter. #2. “Dig­i­tal ther­a­peu­tics” vs. “Men­tal health apps”: A growing…

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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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Funding for digital health start-ups, especially in mental health, fall substantially in Q1’22

Glob­al dig­i­tal health fund­ing falls 36% with few­er megarounds, IPOs (Fierce Health­care): After two years of record-break­ing invest­ment in dig­i­tal health, cap­i­tal flow into the sec­tor took a dive in the first quar­ter of 2022. The glob­al dig­i­tal health mar­ket saw fund­ing decrease 36% from the fourth quar­ter of 2021, total­ing $10.4 bil­lion, as investors reacted…

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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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