Whoop defends Blood Pressure Insights as FDA calls it a medical device
Whoop’s Blood Pressure Insights feature has drawn the attention of US regulators. The FDA says the tool qualifies as a medical device, and Whoop strongly disagrees.
A different view on what counts as medical
To remind, the blood pressure feature appears on the top-tier Whoop MG device. It is a major selling point and one of the things that distinguishes it from the 5.0 version.
The feature was designed to help users make smarter decisions about training and recovery by seeing how blood pressure relates to sleep, stress and strain. We don’t really know the exact details on how blood pressure values are calculated. But you do need to calibrate it with a cuff, then it seems to use a sleep-based model to estimate nightly values.
Whoop insists this feature is about wellness, not medicine. They’re not offering real-time blood pressure, and they clearly state the tool is not for diagnosis or treatment. Members must even acknowledge this during setup. They cite the 21st Century Cures Act as support, which makes room for software tools aimed at promoting healthy living without being regulated as medical devices.
And they’re not alone in that thinking. Other wearables have tracked metrics like respiratory rate, HRV and skin temperature under the same “wellness” umbrella. So from Whoop’s point of view, blood pressure is just another data point for those trying to fine-tune their performance.
But the FDA sees it differently.
FDA raises red flags
The agency’s letter outlines why it believes Blood Pressure Insights crosses a regulatory line. The key issue is intent. Even if Whoop doesn’t say the tool diagnoses anything, presenting daily systolic and diastolic values suggests a medical purpose. Especially when combined with color-coded readings and app language like “higher blood pressure may indicate poor sleep.”
That alone is enough to qualify it as a medical device under US law. The FDA also points out that people could easily use this feature to monitor hypertension, with serious consequences if the estimates are inaccurate. The agency says it has already seen users treating the feature as a diagnostic tool, regardless of disclaimers.
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They argue that wellness features are only exempt from regulation if they are unrelated to disease. Blood pressure, by nature, is not. And that puts Whoop’s approach in conflict with existing policy.
What happens next
So far, Whoop is standing firm. The feature remains available in all markets, including the US, for members on the Whoop Life plan. They continue to recommend regular calibration with a cuff and say they are committed to user access and transparency.
In practical terms, the FDA’s warning does not force an immediate takedown. But it signals that Whoop could face penalties if they continue to offer Blood Pressure Insights without regulatory clearance.
Whether this turns into a wider standoff or gets resolved depends on how far either side is willing to go. Whoop might need to address how they market the product. The company has already earned FDA clearance for its ECG feature, so it’s not unfamiliar with the process. But it’s clear they see a line between that and what they’re doing with blood pressure.
For now, the feature stays live. But the debate over what qualifies as wellness tech is far from over.
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