STAT+: FDA drops enforcement against Whoop after it tweaks blood pressure feature

The Food and Drug Administration quietly told wearable maker Whoop last week that it would not take further enforcement action over a controversial feature that gives users a reading of their blood pressure. In July 2025, the agency warned Whoop for releasing its Blood Pressure Insights feature without clearance, saying it was a medical device that required review. “The product is intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension,” the agency wrote. Whoop argued at the time that the feature could be released without review because it was intended for wellness purposes and not to diagnose or treat a disease. “We won’t let regulatory overreach dictate how people access their own health data,” CEO Will Ahmed wrote at the time.Continue to STAT+ to read the full story…