Apple Watch Hypertension Detection Wins FDA Clearance for Global Rollout

Apple's hypertension detection system for the Apple Watch has received clearance from the U.S. Food and Drug Administration and will launch next week, becoming available in over 150 countries including the U.S., European Union, and Hong Kong. The feature uses the Apple Watch’s optical heart sensor to monitor how blood vessels respond to heartbeats over a 30-day period and alerts users if signs of chronic hypertension are detected, encouraging them to consult healthcare providers. This technology, developed with advanced machine learning models trained on data from more than 100,000 participants, will be supported on Apple Watch Series 9, 10, 11, Ultra 2, and Ultra 3 models running watchOS 26. Apple’s expansion of health monitoring capabilities in its wearables reflects growing competition in the sector with rivals like Samsung, Garmin, and Oura also advancing their health features. Hypertension affects approximately 1.3 billion adults worldwide and is a significant risk factor for serious health conditions, making early detection via consumer devices a potentially impactful development. This marks a continued trend of consumer wearables blurring the lines between fitness gadgets and medical devices.