FDA backs off enforcement on Whoop’s blood pressure reading after updates

The FDA told wearable maker Whoop it would not pursue further enforcement action over its Blood Pressure Insights feature after tweaks; the agency had previously warned in 2025 that the reading constituted a medical device requiring clearance, a stance Whoop disputed by labeling the feature wellness-focused. Experts warn that even with these tweaks, the updated wellness guidance remains ambiguous and could pose risks to users.