FDA clearance

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

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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

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

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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?

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

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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

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

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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