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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Debate: Will digital therapeutics gain the required levels of awareness, adoption, reimbursement and fulfillment to become sustainable?

Can dig­i­tal ther­a­peu­tics become prof­itable? (MedTech­Dive): In 2020, the Food and Drug Admin­is­tra­tion cleared Akili Inter­ac­tive’s video game to improve atten­tion in kids with ADHD. It was the first time that a video game for treat­ment was cleared by the agency, and is one exam­ple of a dig­i­tal ther­a­peu­tic, a class of soft­­ware-based treat­ments with…

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Six guidelines to navigate the Aduhelm controversy and (hopefully) help patients with Mild Cognitive Impairment and early-stage Alzheimer’s Disease

The approval of a con­tro­ver­sial new drug for Alzheimer’s dis­ease, Aduhelm, is shin­ing a spot­light on mild cog­ni­tive impair­ment — prob­lems with mem­o­ry, atten­tion, lan­guage or oth­er cog­ni­tive tasks that exceed changes expect­ed with nor­mal aging. After ini­tial­ly indi­cat­ing that Aduhelm could be pre­scribed to any­one with demen­tia, the Food and Drug Admin­is­tra­tion now spec­i­fies that…

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Prescription software firm Pear Therapeutics to go public via $1.6 billion SPAC deal, harnessing 3 FDA-authorized products and 14 candidates

Pear Ther­a­peu­tics to Go Pub­lic in Rough­ly $1.6 Bil­lion SPAC Deal (The Wall Street Jour­nal): Med­ical tech­nol­o­gy com­pa­ny Pear Ther­a­peu­tics Inc. has agreed to go pub­lic by merg­ing with a blank-check com­pa­ny with ties to the Pritzk­er Vlock Fam­i­ly Office, bet­ting on the grow­ing role of pre­scrip­tion dig­i­tal ther­a­peu­tics. The pro­posed merg­er would give the…

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US Senator Joe Manchin calls for a new FDA Commissioner to replace current (acting) one who “has repeatedly ignored public health concerns and shown a dereliction of duty” over opioids and aducanumab

Key Demo­c­rat Manchin Bash­es FDA Leader on Alzheimer’s Approval (Bloomberg): Sen­a­tor Joe Manchin, a mod­er­ate Demo­c­rat con­sid­ered a cru­cial vote with­in the party’s slim Sen­ate major­i­ty, said Janet Wood­cock, the tem­po­rary head of the Food and Drug Admin­is­tra­tion, should be quick­ly replaced with a per­ma­nent leader. Manchin blast­ed an FDA deci­sion to approve the controversial…

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