The agency’s updated wellness guidance remains ambiguous and poses risks to users, experts say
Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.
The Food and Drug Administration quietly told wearable maker Whoop last week that it would not take further enforcement action over a controversial feature that gives users a reading of their blood pressure.
In July 2025, the agency warned Whoop for releasing its Blood Pressure Insights feature without clearance, saying it was a medical device that required review. “The product is intended to provide a measurement or estimation of a user’s blood pressure, which is inherently associated with the diagnosis of hypo- and hypertension,” the agency wrote in its warning letter.
Whoop countered that the feature could be released without review because it was intended for wellness purposes and not to diagnose or treat a disease. “We won’t let regulatory overreach dictate how people access their own health data,” CEO Will Ahmed wrote at the time.
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Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.
