FDA exempts more wearable, AI features from oversight

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

To Be or Not to Be (a Medical Device): FDA Vs. WHOOP

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 ...