HEALTHSTAT NEWS
STAT+: FDA drops enforcement against Whoop after it tweaks blood pressure feature
The FDA notified wearable company Whoop that it would not pursue further enforcement against its Blood Pressure Insights feature after the company made adjustments. In July 2025, the FDA warned Whoop for releasing the feature without clearance, arguing it functioned as an unapproved medical device. Whoop claimed the feature was intended for wellness use, not medical diagnosis, and its CEO criticized regulatory overreach.
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