FDA plans limited regulation of wearable medical devices, boosting Apple, Fitbit, Oura stocks as 50% of Americans use fitness ...

FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less regulatory oversight.

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

In a pair of guidance documents released Tuesday, the regulator clarified the types of wellness features and clinical ...

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 ...

The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.

The FDA announced wearable devices providing non-medical information won't face regulation, offering clarity on digital health technology and AI policies.

On December 15, 2025, the US Food and Drug Administration (FDA) issued a press release announcing that FDA eliminated a major ...

The Food and Drug Administration (FDA) updated its guidance on Tuesday to allow more wearables to fall into a general ...

Recently, the U.S. Food and Drug Administration (FDA) issued a guidance document entitled Use of Real-World Evidence to Support ...

FDA’s decision to limit regulations of non-medical grade wearables marks a notable shift toward regulatory restraint in digital health. FDA announced its plan to stop subjecting non-medical grade ...

GE HealthCare Technologies Inc. (NYSE: GEHC) leads with 100 FDA-approved AI devices, concentrating heavily on imaging and diagnostics. Their CleaRecon DL technology sharpens cone-beam CT images using ...