Ahmed said the FDA formally closed its warning letter that cited issues with the wearable health tracking device maker’s Blood Pressure Insights feature. Whoop’s wrist-worn device was touted by the company as capable of providing daily systolic and diastolic blood pressure estimations, “delivering medical-grade health & performance insights.”
The FDA sent Whoop the warning letter in July 2025. It said that the company marketed the Blood Pressure Insights feature as a medical-grade offering without having FDA premarket approval (PMA). The FDA stated that the feature had no authorization for any use, including for the measurement or estimation of a user’s blood pressure.
However, Ahmed says today that the matter with the FDA is closed.
“When the FDA first issued the warning letter, many experts advised Whoop that removing the feature was the only path forward. But we believed in the strength of science and our responsibility to the members who rely on it,” Ahmed wrote on LinkedIn. “That conviction guided our approach throughout this process.”
Ahmed said the company “consistently made clear” that Blood Pressure Insights constituted a wellness feature. He said appropriate safeguards and disclosures outlined that it is “not intended for medical use.”
The Whoop leader also said the company plans to continue working with the FDA to bring more regulated medical technologies to market. This comes on the heels of a major funding round that included medtech giant Abbott in the spring.
“We appreciated the FDA’s engagement throughout this process,” Ahmed said. “We also welcome the agency’s updated wellness guidance, which provides greater clarity around the distinction between wellness products and medical devices.”
