Apple Watch Hypertension Notifications Receive Clearance from US FDA

The new Apple Watch hypertension notifications that Apple announced alongside its new watch models on Tuesday have just received clearance from the US Food and Drug Administration (FDA). Apple stated that the feature would be available in more than 150 countries and regions, including the US and the EU, later this month; however, the company was still awaiting clearance from the FDA and other regulators.

Hypertension notifications will notify Apple Watch users when signs of chronic high blood pressure are detected. The smartwatches will do so by using data from their optical heart sensors to analyze how a user’s blood vessels respond to the heartbeats over 30-day periods.

Apple said that it developed these new hypertension notifications with advanced machine learning and training data from multiple healthcare studies totaling over 100,000 participants. “While hypertension notifications will not detect all instances of hypertension, with the reach of Apple Watch, the feature is expected to notify over 1 million people with undiagnosed hypertension within the first year,” the company said on Tuesday.

Hypertension notifications won’t be exclusive to the new Apple Watch Series 11, Ultra 3, and SE2 Apple announced earlier this week. They will also be coming to the older Apple Watch Series 9, Series 10, and SE2 models with the release of watchOS 26 next week. The software update will also enable a new Sleep Score feature on Apple Watch Series 6 or later, Apple Watch SE 2 or later, and all Apple Watch Ultra models.