510(k) clearance

Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA

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FDA’s enforce­ment dis­cre­tion for dig­i­tal health is more ambigu­ous than ever in 2021 (Mobi­Health­News):

The dig­i­tal health ecosys­tem has swelled to encom­pass a broad range of prod­ucts over the years.

On one end of the spec­trum is soft­ware-as-med­ical-devices (SaMD) and pre­scrip­tion dig­i­tal ther­a­peu­tics, prod­uct cat­e­gories for which a com­pre­hen­sive reg­u­la­to­ry strat­e­gy and engage­ment with the FDA are manda­to­ry. On the oth­er are well­ness apps and oth­er low-risk dig­i­tal tools that like­ly spend more time wor­ry­ing about over­sight from the Fed­er­al Trade Com­mis­sion than the health reg­u­la­tor. [Read more…] about Tip for dig­i­tal health start-ups: To nav­i­gate reg­u­la­to­ry gray areas, “engage ear­ly and engage often” with the FDA

Portable brain assessment device by Headsafe secures 510(k) FDA clearance

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FDA Clears Nurocheck, Portable Device to Quick­ly Assess Brain Health (MS News Today):

“A portable device that can quick­ly mea­sure elec­tri­cal activ­i­ty in the brain and relay it to doc­tors via a smart­phone app, called the Nurochek sys­tem, has been cleared by the Unit­ed States Food and Drug Admin­is­tra­tion (FDA) for use as a med­ical device. [Read more…] about Portable brain assess­ment device by Head­safe secures 510(k) FDA clearance

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