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

Regulatory Scrutiny - FDA issued a warning letter to Whoop regarding its blood pressure feature, alleging lack of proper approvals [1] - The core of the issue is whether the blood pressure feature is for wellness insights or for diagnosing/treating medical conditions like hypertension [1] - FDA considers the feature a medical device requiring clinical trials and testing for accuracy if it's used to diagnose, cure, treat, or prevent disease [1] - Whoop has 15 days to respond to the FDA [1] Company Stance and Industry Implications - Whoop defends its blood pressure feature as providing performance and wellness insights, similar to heart rate tracking, protected by the 21st Century Cures Act [1][3] - Whoop believes the FDA doesn't understand the broader wellness insights gained from blood pressure data [1] - The outcome could set a precedent for other companies like Apple, Garmin, and Amazon (Aura Ring) that may develop similar features [1] Technological and Market Context - The technology for blood pressure measurement in wearables is relatively new and its accuracy and application to wellness are under scrutiny [1] - The FDA wants to ensure research supports the accuracy and safety of such devices before they are marketed for medical purposes [1] - Whoop is among the first to market with a wrist wearable that tracks blood pressure [1]