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

By SharpBrains | December 20, 2022

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

By SharpBrains | March 23, 2022

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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The FDA clears Somryst, Pear’s digital therapeutic to treat chronic insomnia

By SharpBrains | March 30, 2020

Pear gets FDA clear­ance for insom­nia ther­a­peu­tic (Med­C­i­ty News): “Pear Ther­a­peu­tics received mar­ket­ing autho­riza­tion for its third prod­uct — a dig­i­tal ther­a­peu­tic intend­ed to treat chron­ic insom­nia. Called Som­ryst, the app is avail­able by pre­scrip­tion only. It con­sists of a nine-week pro­gram that includes cog­ni­tive behav­ioral ther­a­py and restrict­ing sleep to a lim­it­ed win­dow of time

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