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

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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Innovation in COVID times: Otsuka and Click Therapeutics announce fully virtual clinical trial, leveraging Verily’s Project Baseline

Otsu­ka launch­es piv­otal tri­al of dig­i­tal ther­a­peu­tics for depres­sion (Med­C­i­ty News): Otsu­ka Phar­ma­ceu­ti­cal is launch­ing a vir­tu­al study to see if dig­i­tal ther­a­peu­tics can reduce depres­sion symp­toms. It’s the next step in a part­ner­ship between the Tokyo-based drug­mak­er and Click Ther­a­peu­tics, a dig­i­tal health start­up that is devel­op­ing pro­grams for smok­ing ces­sa­tion, depres­sion and insomnia.

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The landscape of digital mental health apps: huge unmet needs, quality concerns, app stores asked to ensure transparency

Address­ing the men­tal health cri­sis (Phar­ma Field): Each day we find out more about the men­tal health effects of the pan­dem­ic. Ear­ly on, the Office for Nation­al Sta­tis­tics found that one in five Britons report­ed symp­toms of depres­sion, com­pared with one in 10 before. And, accord­ing to a recent study led by the Uni­ver­si­ty of Nottingham…

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FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation

FDA Releas­es Arti­fi­cial Intelligence/Machine Learn­ing Action Plan (FDA press release): Today, the U.S. Food and Drug Admin­is­tra­tion released the agency’s first Arti­fi­cial Intelligence/Machine Learn­ing (AI/ML)-Based Soft­ware as a Med­ical Device (SaMD) Action Plan. This action plan describes a mul­ti-pronged approach to advance the Agency’s over­sight of AI/ML-based med­ical soft­ware … The AI/ML-Based Soft­ware as a…

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Startup Big Health raises $39M to universalize access to cognitive behavioral therapy (CBT) for anxiety and poor sleep

Big Health Hones Dig­i­tal Men­tal Health Ther­a­py With $39M Series B (Crunch­base): “Start­up Big Health believes indi­vid­u­als can improve their men­tal health through its tech­nol­o­gy that focus­es on cog­ni­tive behav­ioral ther­a­py ver­sus med­ica­tion or the help of human ther­a­pists. On Thurs­day it raised $39 mil­lion in a Series B financ­ing to advance that objective.

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