FDA declines further action on Whoop blood-pressure feature after earlier warning and company adjustments

The Food and Drug Administration notified wearable maker Whoop last week that it would not take further enforcement action over the company's Blood Pressure Insights feature. @statnews reported that the agency had warned Whoop in July 2025 for releasing the feature without clearance.

The FDA stated at the time that the product was intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension.

Whoop maintained that the feature could be released without review because it was intended for wellness purposes and not to diagnose or treat a disease. ” The FDA’s decision came after Whoop made adjustments to the feature, according to @statnews. The agency’s updated wellness guidance on such tools remains in place.