The FDA's warning to Whoop over blood pressure estimates
In July 2025 the agency said a wearable that estimates blood pressure is a medical device, whatever the disclaimer says. Whoop disagreed.
Kivorent News desk, published , 1 min read
This is a look back at an event from . We wrote it on November 11, 2026, from the sources listed at the end.
What to know
- The FDA sent Whoop a warning letter on July 14, 2025, about its Blood Pressure Insights feature.
- The agency said estimating blood pressure is tied to diagnosing high and low blood pressure, so the feature needed clearance.
- Whoop argued the feature was a wellness tool and said it would keep offering it.
The argument over what a fitness tracker is allowed to tell you came to a head on July 14, 2025. That day the Food and Drug Administration sent a warning letter to Whoop about Blood Pressure Insights, a feature that estimates the wearer's blood pressure from the band's sensors. This account draws on an analysis by the law firm Mintz.
The FDA's position
The agency said the feature was a medical device that had been put on the market without clearance. Its reasoning had three parts:
- Blood pressure is a diagnostic measure. An estimate of it is tied to identifying hypertension and hypotension, so the feature is intended for diagnosis or disease management.
- It is not low risk. A wrong estimate could lead someone to ignore a real problem.
- Disclaimers do not settle it. Saying a product is not for medical use carries little weight if people use it to track a medical condition.
Whoop's position
Whoop had met with the FDA in May and set out its case in a June letter. It argued that the feature encourages a healthy lifestyle and falls under an exemption in federal law for such products. In public, it said the feature helps people understand how their bodies respond to daily life and is not meant to diagnose or treat anything. It said it would keep offering the feature.
Why it mattered
Every wearable maker was watching, because the same question applied to their own roadmaps: can a consumer device show an estimate of a clinical measurement without becoming a regulated medical product?
The answer changed within six months. In January 2026 the FDA revised its wellness policy to say that noninvasive estimates of measures such as blood pressure can qualify as wellness features under set conditions. We cover that in what the FDA's 2026 wellness rules let your wearable tell you.
This article is general information about how technology works. It is not medical advice. Talk to a clinician about your own health.
Sources
- FDA warning letter reminds industry that wellness claims only go so far, Mintz, July 21, 2025
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