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World of Software > News > Apple Watch hypertension alerts feature receives FDA clearance – 9to5Mac
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Apple Watch hypertension alerts feature receives FDA clearance – 9to5Mac

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Last updated: 2025/09/11 at 10:01 PM
News Room Published 11 September 2025
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When Apple announced the new Apple Watch Series 11 and Apple Watch Ultra 3 this week, it unveiled its latest health feature: hypertension notifications. At the time, the company said it expected clearance from the Food and Drug Administration in the United States “soon.”

As of Thursday night, that clearance has officially been granted, and the hypertension notifications feature is set to launch next week.

Apple says that hypertension notifications will be available in more than 150 countries and regions around the world at launch next week, including the US, EU, Hong Kong, and New Zealand.

The new hypertension notifications feature will be available on the new Apple Watch Series 11 and Apple Watch Ultra 3, alongside the Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2.

Here’s how Apple describes the feature:

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.

Apple says its new Hypertension Notification Feature could alert nearly half of users with high blood pressure, including an even greater share of those with more severe Stage 2 hypertension. The feature runs passively in the background on Apple Watch rather than acting as a formal screening tool, and Apple emphasizes that not everyone with hypertension will receive a notification.

In testing, the feature reached 95.3% specificity in the Normal category, meaning many people flagged without full hypertension still showed elevated readings. Apple says this helps raise awareness and encourages proactive conversations with doctors about long-term risks like heart disease, stroke, and kidney issues.

Apple says it expects the feature to notify over 1 million people with undiagnosed hypertension within the first year.

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