The FDA has granted clearance for Apple’s hypertension detection feature for the Apple Watch, according to a 9to5Mac report.
Apple unveiled the new feature alongside the Apple Watch Series 11 and Apple Watch Ultra 3 at its iPhone media event on Tuesday. Apple said at the time that it was expecting the FDA to approve hypertension alerts “soon.” That clearance has now been granted.
The feature will also be available on Apple Watch Series 9 and later, as well as the Apple Watch Ultra 2 and later models. It will launch in the United States, the European Union and 150+ other countries and regions, although some countries may require regulatory approval from their own agencies.
Apple explains how hypertension detection works on the Apple Watch:
Hypertension notifications on Apple Watch use data from the optical heart sensor to analyze how a user’s blood vessels respond to the beats of the heart. The algorithm works passively in the background reviewing data over 30-day periods, and will notify users if it detects consistent signs of hypertension. These notifications provide users with impactful insights into their health as it relates to this widespread condition simply by wearing their Apple Watch, so they can begin making potentially lifesaving behavioral changes or start treatment to reduce their risk of serious, long-term health events.
Like all of the health features on Apple Watch, hypertension notifications are grounded in rigorous scientific validation. The feature was developed with advanced machine learning and training data from multiple studies totaling over 100,000 participants. Its performance was then validated in a clinical study of over 2,000 participants. While hypertension notifications will not detect all instances of hypertension, with the reach of Apple Watch, the feature is expected to notify over 1 million people with undiagnosed hypertension within the first year.
Apple says hypertension affects approximately 1.3 billion adults around the globe. The affliction often has no symptoms, and since many affected individuals don’t regularly visit their doctor. When they do make a doctor visit, the issue can be easily missed by the single blood pressure measurement.
“Hypertension is the leading preventable cause of heart attack and stroke, yet millions remain undiagnosed,” said Harlan Krumholz, MD, SM, cardiologist and scientist at Yale University and Yale New Haven Hospital. “Making accurate detection easy and part of daily life can help people get care earlier and prevent avoidable harm.”
The hypertension detection feature will be included in the watchOS 26 release when it rolls out on Monday, September 15.
