STAT+: After warning letter, Whoop and FDA in discussions about controversial blood pressure feature

▤ Summary

Whoop has not resolved a dispute with the U.S. Food and Drug Administration over a blood-pressure estimation feature the company launched last year. The FDA issued a warning letter in July saying the feature functions as a medical device that requires agency review, while Whoop maintains the feature is a wellness product and therefore exempt. In January the FDA updated guidance clarifying when general wellness products may provide blood pressure information, including limits on noninvasiveness and on mimicking clinical values without validation. The story highlights ongoing discussions between Whoop and the FDA and is published as a STAT+ exclusive.

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