FDA drops enforcement against Whoop after it tweaks blood pressure feature

Mario covers know-how in well being care, together with FDA regulation of synthetic intelligence; how Medicare pays for well being tech; the usage of AI in medical care; psychological well being chatbots; and shopper wearables. He’s additionally the co-author of the free, twice weekly STAT Well being Tech e-newsletter. You possibly can attain Mario on Sign at mariojoze.13.

The Meals and Drug Administration quietly advised wearable maker Whoop final week that it will not take additional enforcement motion over a controversial function that offers customers a studying of their blood stress.

In July 2025, the company warned Whoop for releasing its Blood Strain Insights function with out clearance, saying it was a medical system that required overview. “The product is meant to offer a measurement or estimation of a person’s blood stress, which is inherently related to the prognosis of hypo- and hypertension,” the company wrote.

Whoop countered that the function may very well be launched with out overview as a result of it was supposed for wellness functions and to not diagnose or deal with a illness. “We received’t let regulatory overreach dictate how individuals entry their very own well being information,” CEO Will Ahmed wrote on the time.