STAT+: After warning letter, Whoop and FDA in discussions about controversial blood pressure feature
Whoop is currently in discussions with the FDA regarding a blood pressure feature that the agency claims requires regulatory review. The FDA previously warned Whoop that the feature, which estimates users' blood pressure, is classified as a medical device. Whoop contends that the feature is intended for wellness purposes and should be exempt from such review.
- ▪The FDA warned Whoop last July that its blood pressure feature requires regulatory review.
- ▪Whoop argues that the feature is for wellness purposes and should be exempt from FDA oversight.
- ▪In January, the FDA updated its guidance on wellness products to include blood pressure information.
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STAT PlusHealth tech After warning letter, Whoop and FDA in discussions about controversial blood pressure feature The agency warned Whoop last July that the feature required regulatory review Manage alerts for this article Email this article Share this article Ricky Bloomfield, chief medical officer at Oura (left), and Alex Vannoni, head of health care products at Whoop, participate in a session on wearables at the Breakthrough Summit West.Jack Simpson for STAT By Mario AguilarMay 21, 2026 Health Tech Correspondent Mario Aguilar[email protected]Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables.
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