Growing backlash against the FDA approval of unproven Alzheimer’s treatment Aduhelm, by Biogen

By SharpBrains | June 14, 2021

ICER Issues State­ment on the FDA’s Approval of Adu­canum­ab for Alzheimer’s Dis­ease (Insti­tute for Clin­i­cal and Eco­nom­ic Review): The Insti­tute for Clin­i­cal and Eco­nom­ic Review (ICER) believes that the FDA, in approv­ing adu­canum­ab (Aduhelm™, Bio­gen) for the treat­ment of Alzheimer’s dis­ease, has failed in its respon­si­bil­i­ty to pro­tect patients and fam­i­lies from unproven treat­ments with…

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Akili Interactive Labs raises $160M in equity and debt to transform cognitive healthcare via prescription videogame treatments

By SharpBrains | May 26, 2021

Akili rais­es $110m to build its dig­i­tal ther­a­peu­tics pipeline (phar­mafo­rum): Endeav­or­Rx became the first and so far only approved pre­scrip­tion video game treat­ment in the US when it was cleared by the FDA last year to treat atten­­tion-deficit hyper­ac­tiv­i­ty dis­or­der (ADHD), and has also been giv­en a green light in Europe.

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Ohio joins Indiana and Kentucky in funding Pear Therapeutics’ digital addiction treatments

By SharpBrains | April 26, 2021

Ohio is third state to fund Pear’s dig­i­tal ther­a­peu­tics to tack­le addic­tion (phar­mafo­rum): The com­pa­ny has been push­ing for more reim­burse­ment of its three mar­ket­ed DTx prod­ucts in the US fol­low­ing a first FDA approval in 2017. Pear said that the Ohio Depart­ment of Men­tal Health and Addic­tion Ser­vices (OhioMHAS) and Recov­ery­Ohio are pro­vid­ing access to…

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

By SharpBrains | January 25, 2021

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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