Apple has received U.S. Food and Drug Administration clearance for a new Apple Watch feature that can notify users of possible long-term high blood pressure, with the rollout set for next week, Bloomberg reported Friday.
Apple says the hypertension notifications will run on Apple Watch Series 9 and later, and Apple Watch Ultra 2 and later, when watchOS 26 becomes available on Monday, Sept. 15. The company previously said clearance was expected this month.
The tool looks for patterns in the optical heart sensor’s data over 30-day periods that are linked to high blood pressure and can tell users to see a doctor. Apple says it “will not detect all instances of hypertension.” The company says that consumers should double-check their results by using a third-party cuff to take blood pressure readings for seven days and then sending them to a doctor.
Apple has set eligibility limits. The feature is not intended for people under 22, for those already diagnosed with hypertension, or during pregnancy.
“With powerful new health features — hypertension notifications and sleep score — plus longer battery life, a more scratch-resistant glass display, and 5G cellular, all in a thin and comfortable design users love, Apple Watch Series 11 is an indispensable companion that supports users’ health, fitness, safety, and connectivity throughout the day and night,” said Stan Ng, Apple’s vice president of Apple Watch and Health Product Marketing.
At its product announcement on September 9, Apple showed off the feature along with the Apple Watch Series 11 and a new line of iPhones.
Regulatory context: When the FDA gives a device “clearance,” it usually means that it has received a 510(k) premarket notification stating that it is very similar to a legally marketed device. This is different from “approval,” which is a more strict process. The government argues that 510(k) approval lets companies sell gadgets that fulfill safety and performance standards for the use they were made for.
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