Regulatory Landscape - The company is in disagreement with the FDA regarding the regulation of its Blood Pressure Insights feature, arguing it falls under wellness, not medical device, use cases according to the 21st Century Cures Act [2][3][5] - The company believes the FDA is misinterpreting the intended use of the blood pressure feature, which it argues has wellness applications supported by peer-reviewed research [4][6] - The company has responded to the FDA's warning letter, asserting its compliance with the law and expressing a commitment to continued engagement [9] Product & Innovation - The company has developed Blood Pressure Insights, an innovative feature providing daily blood pressure estimates using a wrist-worn wearable calibrated with a cuff [1] - The company emphasizes the wellness applications of its blood pressure feature, highlighting its potential impact on sleep, stress, and nutrition [2] - The company distinguishes between wellness and medical use cases for blood pressure monitoring, indicating it is also exploring FDA-cleared products for medical diagnosis in the long term [5] - The company highlights that its wearable is one of the first to accurately measure blood pressure from the wrist, and it is accepted in 50 other markets globally [10][11] Business Strategy & Public Relations - The company differentiates its WHOOP 5 data from its medically graded (MG) product by the presence of a medically cleared EKG feature on the latter, which took two and a half years to develop with the FDA [6][7] - The company views its stance as a fight for innovation and Americans' access to health data, believing it will ultimately be seen as being on the right side of history [13] - The company emphasizes the extensive medical disclaimers within its app, clarifying the distinction between wellness and medical capabilities [8]