Apple Watch Hypertension Alerts Get FDA Clearance, Launching Next Week

Apple’s hypertension detection feature for Apple Watch has received FDA clearance and will launch next week, according to 9to5Mac.

When Apple announced the Apple Watch Series 11 and Apple Watch Ultra 3 on Tuesday, the company said it expected FDA approval “soon” for hypertension alerts. That clearance has now been granted.

The feature will be available on Apple Watch Series 9 and later, plus Apple Watch Ultra 2 and later models, expanding beyond the newly announced watches. Hypertension alerts will launch in the U.S. and more than 150 countries, though some regions may require their own independent regulatory approval.

Hypertension notifications use the Apple Watch’s optical heart sensor to analyze blood vessel responses over 30-day periods, alerting users to consistent signs of chronic high blood pressure. The condition affects approximately 1.3 billion adults globally and often goes undiagnosed due to lack of symptoms.

Apple developed the technology using machine learning and training data from studies involving over 100,000 participants. The company validated it in clinical trials with more than 2,000 participants and expects the feature to notify over 1 million people with undiagnosed hypertension within its first year.

Users who receive notifications are advised to monitor their blood pressure for seven days using a third-party cuff and share results with healthcare providers, following American Heart Association guidelines.

Expect the feature to appear as part of watchOS 26 when it rolls out on Monday, September 15.