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

By SharpBrains | March 22, 2021

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…

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

By SharpBrains | May 14, 2020

__ 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…

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

By SharpBrains | May 10, 2016

Akili 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

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