Whoop says FDA is 'overstepping its authority' with warning about blood pressure feature

Whoop says FDA is 'overstepping its authority' with warning about blood pressure feature

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

The FDA Says Whoop’s Blood Pressure Feature Is Illegal, but It’s Still Active (for Now)

The FDA told Whoop that its Blood Pressure Insights feature (available only on the Whoop MG with the top-tier Life membership) runs afoul of the law. The feature is still available for now. Read on for more on what the FDA said, how Whoop responded, and what this may mean for the company going forward.

Whoop Claims FDA Is Overstepping with Warning on Blood Pressure Feature

The U.S. Food and Drug Administration (FDA) issued a warning letter to wearable tech company Whoop on Tuesday, raising concerns about the company marketing a blood pressure feature without proper regulatory approval. The warning targets Whoop’s Blood Pressure Insights (BPI) feature, introduced with its latest hardware in May. Whoop states that BPI provides performance and wellness insights based on estimated blood pressure data to help consumers…

Whoop says FDA is ‘overstepping its authority’ with warning about blood pressure feature – DG Verifications & Stats

The logo for the Food and Drug Administration is seen ahead of a news conference on removing synthetic dyes from America’s food supply, at the Health and Human Services Headquarters in Washington, DC on April 22, 2025. Nathan Posner | Anadolu | Getty Images The U.S. Food and Drug Administration on Tuesday published a warning letter addressed to the wrist wearable company Whoop, alleging it is marketing a new blood pressure feature without proper…

Whoop says FDA is 'overstepping' with blood pressure feature warning

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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 …