Whoop Gets FDA Warning on Blood Pressure Feature Marketing

Whoop received a warning letter from the FDA stating the company was marketing its Blood Pressure Insights feature in the US without marketing clearance or approval.

• FDA determined BPI is intended to provide a measurement or estimation of a user’s blood pressure, which is “inherently associated” with the diagnosis of hypo- and hypertension, and is therefore intended for use in the diagnosis, cure, treatment or prevention of a disease or condition
• FDA urged Whoop to take action to address violations
• Failure to address violations may result in regulatory action, including potential injunction and civil money penalties, being initiated by the ...