The US Food and Drug Administration has formally notified WHOOP that its Blood Pressure Insights (BPI) feature crosses from wellness into medical device territory. The warning sets a precedent for how fitness trackers present sensitive health metrics.
Key Points from the FDA Notice
• BPI is classified as a medical device under federal law rather than a simple wellness tool
• Color-coded readings and daily systolic and diastolic estimates imply clinical diagnosis
• Blood pressure is inherently linked to hypertension and cannot be treated like a simple heart rate variability.
• Inaccurate estimates could prompt risky health decisions by users
• Lack of FDA clearance amounts to a violation of federal regulations
15 Days To Respond
FDA notice is requiring WHOOP to respond within 15 business days or face penalties, injunctions or product confiscation. In response, WHOOP’s CEO Will Ahmed has stood his ground not to remove this feature. He insists BPI is clearly marked as a wellness tool, not a medical device. Instead, it highlights its value for tracking how stress, sleep and strain affect the body.
WHOOP Pushes Back
WHOOP says the Blood Pressure Insights feature is clearly marked as “not for medical use”. Most people have given the feature positive feedback with the company training the model on over 32,000 sessions from more than 11,000 users. They also point out that the FDA already approved their ECG feature, so blood pressure monitoring follows a different set of rules.
This warning could be an alert for every wearable device company to reconsider their approach and rethink how they present health insights. Medical clearance for certain features that could be introduced to enforce particular rules, shaping the next wave of wellness technology.
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