Apple Watch Gets FDA Approval for Hypertension Detection

Apple has finally received approval from the U.S. Food and Drug Administration (FDA) for its new hypertension detection feature on the Apple Watch. This means the feature is ready to launch next week.

The news comes right after Apple introduced the Apple Watch Series 11 and Apple Watch Ultra 3 at its 2025 event. At that time, Apple said they were waiting for FDA clearance, which has now come faster than expected.

This health feature will not only work on the latest models but also on Apple Watch Series 9 and newer, as well as the Apple Watch Ultra 2 and newer versions.

The hypertension alerts will be available in the U.S. and more than 150 other countries. However, in some regions, users may need to wait for local approval before they can access it.

The system uses the Apple Watch’s optical heart sensor to check blood vessel responses over 30 days. It looks for signs of high blood pressure, a condition that affects over 1.3 billion people worldwide but often goes unnoticed.

If the watch detects possible issues, it will suggest users confirm by tracking their blood pressure with a cuff for seven days and then share results with doctors.

This new feature will be introduced with watchOS 26, which starts rolling out on Monday, September 15, 2025.

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