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Neuroplasticity, Brain Fitness and Cognitive Health News

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Novartis dissolves agreement to market Pear Therapeutics’ prescription digital therapeutics for substance/ opioid abuse

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As San­doz returns mar­ket­ing rights for dig­i­tal ther­a­peu­tics to Pear, what does it mean for co-pro­mote arrange­ments? (MM&M):

San­doz, the gener­ics divi­sion of Novar­tis, is alter­ing com­mer­cial course, return­ing mar­ket­ing duties for two pre­scrip­tion dig­i­tal ther­a­peu­tics (DTx) back to Pear Ther­a­peu­tics. The move, which some had antic­i­pat­ed, comes 18 months after the two signed a co-pro­mo­tion deal.

Since the Sandoz/Pear pact was wide­ly seen as a lit­mus test of sorts for pharma’s role in help­ing dis­trib­ute this nascent tech­nol­o­gy, the com­mer­cial break-up rais­es ques­tions about the via­bil­i­ty of such part­ner­ships going for­ward. It also high­lights the par­ties’ some­times con­flict­ing pri­or­i­ties: Read the rest of this entry »

May “industry review boards” contribute to the wider adoption of virtual and augmented reality for physical and mental health?

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Indus­try review boards are need­ed to pro­tect VR user pri­va­cy (World Eco­nom­ic Forum blog):

It seemed like a game when Riley first start­ed the vir­tu­al real­i­ty (VR) maze … A month after play­ing the game, Riley was turned down for a new life-insur­ance pol­i­cy. Giv­en his excel­lent health, he couldn’t under­stand why. Sev­er­al appeals lat­er, the insur­ance com­pa­ny dis­closed that Riley’s track­ing data from the VR maze game revealed behav­ioral move­ment pat­terns often seen among peo­ple in the very ear­ly stages of demen­tia Read the rest of this entry »

Can digital Cognitive Behavioral Therapy (CBTi) become the universal first-line treatment for insomnia?

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Pear Ther­a­peu­tics’ dig­i­tal insom­nia ther­a­peu­tic will put FDA’s Pre­Cert frame­work through its paces (Mobi­Health­News):

Pre­scrip­tion dig­i­tal ther­a­peu­tics com­pa­ny Pear Ther­a­peu­tics announced late last week that it has filed an FDA mar­ket­ing autho­riza­tion for Som­ryst, its dig­i­tal cog­ni­tive behav­ioral ther­a­py for the treat­ment of adults with chron­ic insom­nia and depres­sion.

While an approval from the agency would mark the third autho­rized pre­scrip­tion dig­i­tal ther­a­peu­tic for Pear Read the rest of this entry »

The FDA warns consumers not to use unapproved apps and devices to diagnose concussion

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FDA warns pub­lic not to use unap­proved or uncleared med­ical devices to help assess or diag­nose a con­cus­sion (news release):

Today, the U.S. Food and Drug Admin­is­tra­tion is warn­ing the pub­lic not to use med­ical devices mar­ket­ed to con­sumers that claim to help assess, diag­nose or man­age head injury, includ­ing con­cus­sion, trau­mat­ic brain injury (TBI) or mild TBI. Read the rest of this entry »

Problems grow for neuromodulation firm Helius Medical Technologies

Investor Alert: Kaplan Fox Inves­ti­gates Helius Med­ical Tech­nolo­gies, Inc. (press release):

NEW YORKFeb. 7, 2019 /PRNewswire/ — Kaplan Fox & Kil­sheimer LLP has been inves­ti­gat­ing claims on behalf of investors of Helius Med­ical Tech­nologiues, Inc. (“Helius” or the “Com­pa­ny”) (Nas­daq: HSDT).

On Jan­u­ary 22, 2019, after the mar­ket opened, White Dia­mond Research pub­lished Read the rest of this entry »

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