Whoop
After warning letter, Whoop and FDA in discussions about controversial blood pressure feature
· Reported by statnews.com
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 Aguilar SAN FRANCISCO — Wearable maker Whoop has not resolved a dispute with the Food and Drug Administration over a blood pressure feature the company launched last year, according to a top health executive at the company. FDA warned Whoop last July over the feature that gives users a daily estimate of their systolic and diastolic blood pressure, saying that it’s a medical device that requires agency review.
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