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FDA drops enforcement against Whoop after it tweaks blood pressure feature
statnews.com • • business
Key Points:
- The FDA informed wearable maker Whoop last week that it would not pursue further enforcement regarding the company's Blood Pressure Insights feature.
- In July 2025, the FDA had warned Whoop that the feature, which provides blood pressure readings, was considered a medical device requiring regulatory clearance.
- The agency's initial concern was that the feature's blood pressure measurements could be used to diagnose conditions like hypo- and hypertension.
- Despite the warning, the FDA has now decided not to take additional action against Whoop over this feature.
