FDA Ends Enforcement Against Whoop Blood Pressure Feature

The U.S. Food and Drug Administration has ended its enforcement action against wearable company Whoop over a blood pressure tracking feature, allowing the tool to remain available to users. The resolution, confirmed on June 23, concludes a nearly year-long dispute that began in the summer of 2025.

The FDA initially raised concerns in August 2025, warning Whoop that its "Blood Pressure Insights" feature on the MG band appeared to function as an unapproved medical device. The agency argued the tool, which provides a blood pressure estimate, was inherently associated with diagnosing conditions like hypertension and therefore required regulatory clearance. Whoop contested the warning, maintaining the feature was for general wellness and not for medical diagnosis or treatment, and never disabled it during negotiations.

To resolve the conflict, Whoop agreed to modify how the feature is presented. The company is removing labels that categorized readings as "normal" or "elevated" and reframing the tool's purpose as providing "wellness insights" rather than offering a diagnostic function. Officials described the change as primarily a wording adjustment that satisfied regulatory concerns.