Instead of making life easier for medical device companies, the FDA’s new wearables guidance makes the market more complex.

Opinion: The Food and Drug Administration's updated guidance on wellness devices will help ensure that products are appropriately positioned in the market—while staying away from unsupported, ...

Smart ring market leader Oura is trying to convince U.S. lawmakers to loosen some health monitoring regulations for wearable ...

Add Yahoo as a preferred source to see more of our stories on Google. Whoop's wearable devices measure metrics including sleep, heart rate and blood pressure. The company received a warning letter ...

Key Takeaways - FDA’s 2026 guidance clarifies when digital health tools fall outside device regulation. Updated policies for clinical decision ...

Under new Food and Drug Administration (FDA) guidance on "low risk" wearable technology and software, AI-powered health tools are rapidly expanding, leading to major implications for cost, access, and ...

Dec 3 (Reuters) - Niche fitness-tracking firms such as WHOOP are coming under increased regulatory scrutiny as technological advances blur the lines between wearable and medical devices, exposing them ...

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On January 6, 2026, the U.S. Food and Drug Administration (“FDA”) published revised final guidance documents on Clinical Decision Support Software (“Revised CDS Guidance”) and its General Wellness ...

An FDA-cleared wrist-worn device reliably detects convulsive seizures in epilepsy monitoring units but can miss focal ...