Apple Watch gets FDA approval for hypertension alerts, rolling out from September 15

Apple has received FDA clearance for its new hypertension alerts feature on the Apple Watch, with the rollout scheduled to begin on September 15 through watchOS 26.

First announced alongside the Apple Watch Series 11 and Apple Watch Ultra 3, the feature will also be available on older models including Apple Watch Series 9 and later, as well as Apple Watch Ultra 2 and later. It will launch across the US and more than 150 countries, although some regions may require additional local approvals.

The hypertension alerts system uses the Apple Watch’s optical heart sensor to monitor blood vessel responses over a 30-day period, notifying users of signs of chronic high blood pressure. Hypertension, which affects an estimated 1.3 billion adults worldwide, is often undiagnosed due to the absence of clear symptoms.

Apple developed the feature using machine learning and data from over 100,000 participants, and further validated it in clinical trials with more than 2,000 people. The company estimates that within its first year, the technology could help identify over one million users with undiagnosed hypertension.