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

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.&#x A0; 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. Whoop argues that the feature is exempt from FDA review because it is intended for wellness purposes. In January, FDA updated its guidance on general wellness products to include those that provide information about blood pressure, provided they are not intended to treat and diagnose disease. To avoid being classified as medical devices, these products also must meet other criteria, including that they be non-invasive and that they “do not include values that mimic those used clinically unless validated.” Continue to STAT+ to read the full story…