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Whoop CEO Will Ahmed on FDA warning: Our blood pressure insight is intended for wellness use only
CNBC Televisionยท 2025-08-14 11:30
Regulatory Landscape - FDA issued a warning letter to Whoop regarding the blood pressure feature on its device [1] - Whoop is pushing back on the FDA's claim that blood pressure insights is a medical device and should be regulated [3] - The company argues that its blood pressure insights feature is intended for wellness, aligning with the 21st Century Cures Act, and should not be regulated as a medical device [4][13] - The company emphasizes the importance of consistent policies and treatment from the FDA, particularly regarding wellness features [12][13] Product & Innovation - Whoop has invested tens of millions of dollars over the last three years in innovating blood pressure insights, which provides a daily estimate of blood pressure after cuff calibration [3] - Whoop's blood pressure insights feature allows users to understand their blood pressure alongside other wellness information like sleep, exercise, and nutrition [3][4] - Whoop has a medically cleared ECG monitoring feature to detect AFib, demonstrating familiarity with the distinction between wellness and medical applications [7] - Whoop 5.0 is more accurate, suggesting continuous improvement in wearable device technology [20] Market Perception & Adoption - Whoop members have shown overwhelmingly positive support for the blood pressure insights feature, finding the daily estimates accurate and valuable [17] - Doctors are starting to become more comfortable using data from wearable devices like Whoop to discuss overall lifestyle, behavior, and health [20] - Wearable devices provide information that allows consumers to take control of their health, aligning with Whoop's goal to help people live longer and healthier [20][21]