HEALTHSTAT NEWS
STAT+: After warning letter, Whoop and FDA in discussions about controversial blood pressure feature
Wearable maker Whoop is in ongoing discussions with the FDA regarding a blood pressure monitoring feature launched last year. The FDA issued a warning letter claiming the feature is a medical device requiring agency review, while Whoop contends it is exempt as a wellness product. The dispute remains unresolved despite the FDA's January guidance update on general wellness products.
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