Wearable tech firm ‘respectfully disagrees’ with agency that blood pressure feature crosses into the regulatory domain of diagnosing disease.
Health tracking wearables giant Whoop has responded to an FDA warning letter issued this week, which asserted that the company was marketing its recently launched Blood Pressure Insights feature as an unapproved medical device. The agency’s concern centered on the feature’s ability to provide users with estimated systolic and diastolic blood pressure values based on overnight physiological data.
Despite Whoop’s efforts to frame the feature as a general wellness tool, the FDA contends that blood pressure estimation crosses into the regulatory domain of diagnosing or managing disease, which requires premarket approval. The agency gave the company 15 business days to respond with a plan for corrective actions.
Whoop subsequently issued a statement “respectfully disagreeing” with the FDA’s position, an indication that it intends to fight its corner on this point. The company stressed that Blood Pressure Insights is not intended as a diagnostic tool but rather as a wellness feature designed to help users understand how their blood pressure responds to variables like sleep quality, stress levels, physical exertion, and recovery.
“Blood Pressure Insights is a wellness feature, not a medical device,” said Whoop’s statement. “It’s designed to help you understand how your body responds to daily life, not to diagnose or treat any condition. Wellness features like this are common in wearable technology, like tracking your respiratory rate or HRV, and provide valuable insights to support better decisions about your performance without requiring FDA clearance.”
Announced in May this year, Whoop’s Blood Pressure Insights tool uses heart rate, heart rate variability, and blood flow patterns recorded during sleep to generate blood pressure estimations. The company says it trained and validated its algorithm on data from over 11,000 members, comparing the outputs with clinical-grade cuff readings. While the FDA did not question the accuracy of the model, it nonetheless views the offering as a regulated function requiring review and clearance.
Like many wearables companies, Whoop’s development of new features stems from a broader effort to expand user understanding of how physiological variables influence performance and wellbeing. The company’s approach reflects a growing trend to provide increasingly sophisticated interpretations of biometric data while navigating the evolving regulatory environment that separates wellness tools from medical devices.
The wearables industry will be watching the outcome of this dispute closely, as it could set important precedents for how wellness features involving health-related data are regulated in the US.
