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FDA announces regulatory exemptions for ‘non-medical grade’ devices
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital ...
The U.S. Food and Drug Administration (FDA) announced on Tuesday that it will limit regulatory oversight of wearable devices ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
On July 14, 2025, FDA issued a warning letter to WHOOP, Inc., notifying the company that its marketing of Blood Pressure Insights (BPI) was neither cleared nor approved. FDA stated that BPI qualifies ...
Katie Palmer covers telehealth, clinical artificial intelligence, and the health data economy — with an emphasis on the impacts of digital health care for patients, providers, and businesses. You can ...
Many Medtech startups view FDA and similar regulatory bodies as a roadblock. Something that is there to get in their way, slow them down, and cost them a fortune. Smart companies see regulations as an ...
The Elena and Miles Zaremski Law Medicine Forum presents: Medical Device Regulation: Going from Bad to Worse...or Better? with George Horvath Innovations in medical device technology hold the ...
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