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FDA Approval Medical Devices Mobile Health Apps

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

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Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Knobbe Martens

FDA Clears First Apple Watch Medical Device Accessory

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The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more

Knobbe Martens

FDA Approves First-Ever Mobile App for Addiction Treatment

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The FDA recently approved the marketing of the first-ever prescription digital therapeutic to be used in the treatment of substance use disorder (SUD)....more

Knobbe Martens

FDA Approves Bayer’s myBETAapp™

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On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

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