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FDA Approval Mobile Health Apps

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

Fenwick & West LLP on

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

Burr & Forman

COVID-19, Mobile Health & the Importance of Maintaining Legal Compliance in an Era of Explosive Growth

Burr & Forman on

It is increasingly important for mobile app developers to ensure their products comply with all governing state and federal laws, and it is critical to understand which business changes might place your product under a...more

Knobbe Martens

FDA Clears First Apple Watch Medical Device Accessory

Knobbe Martens on

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

Knobbe Martens on

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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