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Apple Watch Receives FDA Clearance for Hypertension Notifications

By Diagnostics World Staff 

September 18, 2025 | Last week Apple introduced Apple Watch Series 11, offering the most comprehensive set of health features yet, longer battery life, an even more durable cover glass, and 5G cellular capabilities, all in its thinnest and most comfortable design.  

Among the new features, Apple Watch Series 11 introduced FDA-cleared hypertension notifications, which can alert users if signs of chronic high blood pressure — or hypertension — are detected. Hypertension is the leading modifiable risk factor for heart attack, stroke, and kidney disease, and impacts approximately 1.3 billion adults globally. It is frequently undiagnosed because it often has no symptoms, many people do not see a doctor regularly, and even during a clinical visit, it can be easily missed with a single measurement. 

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 valuable 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. 

The feature was developed with advanced machine learning and training data from multiple studies totaling over 100,000 participants according to the company. 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. 

“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 in Apple’s press release. “Making accurate detection easy and part of daily life can help people get care earlier and prevent avoidable harm.” 

If users receive a hypertension notification, it is recommended that they log their blood pressure for seven days using a third-party blood pressure cuff and share the results with their provider at their next visit, which is consistent with the latest American Heart Association guidelines for the diagnosis and management of hypertension. 

The feature will be available in more than 150 countries and regions — including the U.S. and the EU — this month. Hypertension notifications will be available on Apple Watch Series 9 and later, and Apple Watch Ultra 2 and later, with watchOS 26. 

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