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

The Food and Drug Administration (FDA) informed wearable technology company Whoop last week that it will not pursue further enforcement actions regarding Whoop's blood pressure feature. This decision follows an FDA warning issued in July 2025, which stated that Whoop's Blood Pressure Insights feature, released without prior clearance, was considered a medical device requiring regulatory review. The FDA had asserted that the feature's purpose was to measure or estimate a user's blood pressure, a metric directly linked to the diagnosis of hypotension and hypertension. Whoop, however, maintained that the feature was intended for wellness tracking and not for diagnosing or treating medical conditions, thus arguing it did not require FDA clearance. At the time of the FDA's initial warning, Whoop CEO Will Ahmed stated that regulatory overreach should not impede individuals' access to their personal health data.