Overview

• The FDA has told Whoop it must register and clear its Blood Pressure Insights feature as a medical device, asserting that its estimates are inherently linked to hypertension diagnosis.
• Whoop rejects the agency’s determination, arguing the software is a non-medical wellness tool exempt under the 21st Century Cures Act and will keep the feature active.
• In July, the FDA warned that offering Blood Pressure Insights without authorization violates federal law and Bloomberg reported threats of civil penalties or device seizure.
• Whoop, which previously gained FDA clearance for its Heart Screener product, says it will meet with the agency to seek a constructive resolution.
• The unresolved dispute could set a precedent for how advanced blood-pressure estimates in wearables are regulated across the industry.