FDA Scrutiny: Wearable Makers Face Stricter Rules
Update: 2025-12-03
Description
Fitness trackers like WHOOP are under scrutiny from the FDA, as advanced features blur the line between wearables and medical devices. The FDA is now requiring formal approval for health features, leading to stricter norms for wearable makers. WHOOP received a warning for its blood pressure insights feature, while Apple sought FDA clearance for a hypertension notification feature. This shift could impact competition, increase costs, and potentially lead to health risks if unvalidated devices provide incorrect readings.
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