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FDA clearance

Click Therapeutics raises further $52M to build up digital therapeutics pipeline for depression, insomnia, smoking cessation and more

November 4, 2021 by SharpBrains

Get­ty Images

With Sanofi still on board, Click Ther­a­peu­tics clos­es $52M series B for dig­i­tal ther­a­peu­tics in depres­sion, chron­ic pain and more (Fierce Biotech):

Anoth­er medtech devel­op­er’s plans to cre­ate dig­i­tal ther­a­peu­tics to treat a wide range of ill­ness­es are click­ing into place, thanks to a third mul­ti­mil­lion-dol­lar invest­ment in Click Ther­a­peu­tics in bare­ly a year. [Read more…] about Click Ther­a­peu­tics rais­es fur­ther $52M to build up dig­i­tal ther­a­peu­tics pipeline for depres­sion, insom­nia, smok­ing ces­sa­tion and more

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: acute coronary syndrome, app-based therapeutics, chronic pain, Click Therapeutics, Clickadian, Clickheart, Clickotine, cognitive, cognitive-exercises, depression, digital therapeutics, FDA clearance, insomnia, Otsuka, smoking cessation, treat migraine, treat schizophrenia

Will digital therapeutics complement or replace stimulant medications to address inattention and “silent” cognitive issues?

January 29, 2020 by SharpBrains

___

Akili Inter­ac­tive: Dig­i­tal pedi­atric ADHD ther­a­peu­tic per­forms well with or with­out accom­pa­ny­ing stim­u­lant ther­a­py (Mobi­Health News):

“Dig­i­tal ther­a­peu­tic com­pa­ny Akili Inter­ac­tive has announced the first results of an open-label, mul­ti­site pedi­atric ADHD tri­al pro­vid­ing some patients with the company’s video game-like treat­ment along­side a stim­u­lant medication.

Accord­ing to the com­pa­ny, both those who received the AKL-T01 ther­a­py with (n = 130) or with­out (n = 76) accom­pa­ny­ing stim­u­lant med­ica­tion saw sig­nif­i­cant improve­ments one month after [Read more…] about Will dig­i­tal ther­a­peu­tics com­ple­ment or replace stim­u­lant med­ica­tions to address inat­ten­tion and “silent” cog­ni­tive issues?

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Filed Under: Attention & ADD/ADHD, Brain/ Mental Health, Technology & Innovation Tagged With: adhd, ADHD trial, ADHD-medication, Akili Interactive, AKL-T01, cognitive, cognitive issues, digital therapeutic, FDA clearance, non-invasive neurotechnologies, non-invasive neurotechnology, stimulant medication, video game-like treatment

Large multi-center study to test videogame-like digital therapy as (potentially) FDA-cleared ADHD treatment

May 10, 2016 by SharpBrains

evo_akiliAkili Labs recruits for ADHD tri­al with ambi­tions of FDA clear­ance for dig­i­tal med­i­cine (Med­C­i­ty News)

“Akili Labs has kicked off open enroll­ment for a clin­i­cal tri­al of its Project EVO video game plat­form in a quest to secure for 510(k) clear­ance from the U.S. Food and Drug Admin­is­tra­tion for its lead indi­ca­tion [Read more…] about Large mul­ti-cen­ter study to test videogame-like dig­i­tal ther­a­py as (poten­tial­ly) FDA-cleared ADHD treatment

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: 510(k) clearance, Adderall, adhd, ADHD-Treatment, Akili Labs, attention deficit hyperactivity disorder, digital medicine, digital therapeutics, FDA clearance, Project EVO

AnthroTronix CEO Corinna Lathan to discuss 510(k) FDA clearance of its DANA neurocognitive test at 2014 SharpBrains Virtual Summit

October 16, 2014 by SharpBrains

Corinna_LathanHap­py to share that Dr. Lath­an, CEO of Anthro­Tron­ix, will dis­cuss the brand-new 510(k) FDA clear­ance of their DANA neu­rocog­ni­tive test at the 2014 Sharp­Brains Vir­tual Sum­mit (Octo­ber 28–30th), dur­ing the ses­sion Best prac­tices to assess and enhance brain func­tion via mobile devices and wear­ables.

Dr. Corin­na Lath­an leads Anthro­Tronix, a bio­med­ical engi­neer­ing prod­uct devel­op­ment com­pany and pio­neer in mobile plat­form tech­nol­ogy. Their DANA™ prod­uct is [Read more…] about Anthro­Tron­ix CEO Corin­na Lath­an to dis­cuss 510(k) FDA clear­ance of its DANA neu­rocog­ni­tive test at 2014 Sharp­Brains Vir­tu­al Summit

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Filed Under: Brain/ Mental Health, Technology & Innovation Tagged With: 510(k), 510(k) FDA clearance, AnthroTronix, brain func­tion, Dana, FDA, FDA clearance, mobile devices, neurocognitive, neurocognitive test, wearables

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