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Food and Drug Administration

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

June 6, 2022 by SharpBrains

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

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: anxiety, artificial intelligence, CBT, chronic musculoskeletal pain, cognitive-behavioral-therapy, depression, digital mental health, FDA, Food and Drug Administration, mental health industry, smartphone, Wysa

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

April 21, 2022 by SharpBrains

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?

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: Akili Interactive, digital therapeutic, digital therapeutics, Food and Drug Administration, Pear Therapeutics

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

October 13, 2021 by Kaiser Health News

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

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Filed Under: Brain/ Mental Health Tagged With: Aduhelm, Alzheimer’s Disease, attention-problems, brain bleeding, brain swelling, cognitive problems, dementia, dementia specialists, early-stage Alzheimer’s, Food and Drug Administration, language problems, memory problems, mild-cognitive-impairment, neuropsychological, neuropsychological-tests, normal cognition, primary care physicians, tests

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

June 28, 2021 by Kaiser Health News

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

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: anxiety, BetterHelp, brain-illness, Brightside, cerebral, depression, digital behavioral health, FDA, Food and Drug Administration, Ginger, health apps, mental health, mental illness, mental-health-treatment, Mindstrong Health, TalkLife, Talkspace, Woebot

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

June 23, 2021 by SharpBrains

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

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: digital therapeutics, FDA, Food and Drug Administration, Neuberger Berman Group, patient retention, PEAR, Pear Holdings Corp, Pear Therapeutics, prescription digital therapeutics, prescription software, Pritzker Vlock, reSET, reSET-O, Thimble Point Acquisition Corp, treatment retention

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

June 18, 2021 by SharpBrains

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

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Filed Under: Brain/ Mental Health Tagged With: aducanumab, Aduhelm, Alzheimer's treatments, Alzheimer’s therapy, Alzheimers-disease, Biogen, FDA, Food and Drug Administration, Joe Manchin, opioids, OxyContin, public-health

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