FDA clears Apple Watch blood pressure alert, global rollout set

15 Sep 2025

Cupertino, California: Apple’s smartwatch is set to get a new health tool next week, after U.S. regulators cleared a feature that can help detect hypertension, Bloomberg News reported.

The Food and Drug Administration approved the technology, which Apple previewed at its September 9 event alongside its refreshed iPhone lineup, including the slimmer iPhone Air.

Apple said the tool could flag possible high blood pressure cases in about a million people, though it stressed that it would not detect every instance of hypertension.

According to Bloomberg, the feature uses the watch’s optical heart sensor to monitor how blood vessels respond to heartbeats over a 30-day period. It will be available in 150 countries and rolled out across the Apple Watch Series 9, Series 10, Series 11, and the higher-end Ultra 2 and Ultra 3 models.

Neither Apple nor the FDA immediately responded to requests for comment.

 

 

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