Apple Watch Hypertension Alerts feature receives FDA clearance

When Apple unveiled its new Apple Watch Series 11 and Apple Watch Ultra 3 this week, it announced its latest health feature: hypertension notification. At the time, the company said it hopes clearance from the US Food and Drug Administration will be “quickly.”

As of Thursday night, that clearance has been officially granted, and the hypertension notification feature is scheduled to be released next week.

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

The new hypertension notification feature is available on the Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2, as well as the new Apple Watch Series 11 and Apple Watch Ultra 3.

Here’s how Apple explains the feature:

Use data from the Apple Watch’s hypertension notification optical heart sensor to analyze how your blood vessels respond to heartbeat. The algorithm will passively operate data review data in the background over 30 days, informing users whether it will detect consistent signs of hypertension. These notifications are related to this broad condition simply by wearing an Apple Watch, providing users with valuable health insights, allowing treatments to potentially cause life-saving behavioral changes or reduce the risk of serious, long-term health events.

According to Apple, the new hypertension notification feature could warn almost half of hypertensive users, including an even larger share of people with more severe stage 2 hypertension. Rather than acting as a formal screening tool, this feature runs passively in the background of your Apple Watch, highlighting that not everyone with high blood pressure receives notifications.

In tests, this feature reached 95.3% specificity in the normal category. That is, many people flagged without full hypertension still showed an increase in readings. Apple says this will help raise awareness and encourage active conversations with doctors about long-term risks such as heart disease, stroke and kidney problems.

Apple says it expects the feature to notify more than 1 million people with undiagnosed hypertension within a year.

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