Food and Drug Administration

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

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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 [Read more…] about AI-enabled chat­bot Wysa receives FDA Break­through Device des­ig­na­tion for patients with chron­ic pain, depres­sion and anxiety

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

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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 FDA indications.

Now, as the mar­ket is fur­ther devel­op­ing, these com­pa­nies have built up big ambi­tions. [Read more…] about Debate: Will dig­i­tal ther­a­peu­tics gain the required lev­els of aware­ness, adop­tion, reim­burse­ment and ful­fill­ment to become sustainable?

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

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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 the pre­scrip­tion drug be giv­en to indi­vid­u­als with mild cog­ni­tive impair­ment or ear­ly-stage Alzheimer’s, the groups in which the med­ica­tion was studied.

Yet this nar­row­er rec­om­men­da­tion rais­es ques­tions. What does a diag­no­sis of mild cog­ni­tive impair­ment mean? Is Aduhelm appro­pri­ate for all peo­ple with mild cog­ni­tive impair­ment, or only some? And who should decide which patients qual­i­fy for treat­ment: demen­tia spe­cial­ists or pri­ma­ry care physi­cians? [Read more…] about Six guide­lines to nav­i­gate the Aduhelm con­tro­ver­sy and (hope­ful­ly) help patients with Mild Cog­ni­tive Impair­ment and ear­ly-stage Alzheimer’s Disease

The explosion of mental health apps raises substantial opportunities–and also difficult questions

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In the eyes of the tech indus­try, men­tal health treat­ment is an area ripe for disruption.

In any giv­en year, 1 in 5 adults in the U.S. expe­ri­ence a form of men­tal ill­ness, accord­ing to fed­er­al esti­mates. And research indi­cates only about half of them receive treat­ment in a sys­tem that is under­staffed and ill dis­trib­uted to meet demand.

For tech star­tups look­ing to cash in on unmet need, that trans­lates into more than 50 mil­lion poten­tial cus­tomers. [Read more…] about The explo­sion of men­tal health apps rais­es sub­stan­tial opportunities–and also dif­fi­cult questions

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

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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 com­bined com­pa­ny a pro for­ma equi­ty val­ue of about $1.6 bil­lion. [Read more…] about Pre­scrip­tion soft­ware firm Pear Ther­a­peu­tics to go pub­lic via $1.6 bil­lion SPAC deal, har­ness­ing 3 FDA-autho­rized prod­ucts and 14 candidates

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

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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 Alzheimer’s ther­a­py Aduhelm despite con­flict­ing evi­dence that the Bio­gen Inc. drug works and an over­whelm­ing­ly neg­a­tive vote against the ther­a­py by agency advis­ers. The FDA rul­ing led three mem­bers of that pan­el to quit in protest… [Read more…] about 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