FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
FDA announces wearable devices providing non-medical info won't face regulation, offering clarity on digital health ...
FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...
In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
The FDA has announced that it will relax portions of its regulatory framework governing wearable health devices, a move the agency says is designed to encourage innovation and expand consumer access ...
Americans cannot rely on the Food & Drug Administration (FDA) to guarantee that medical devices are safe, and a recent Government Accountability ...
After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...
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