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 countered 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.
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