Apple has received clearance from the U.S. Food and Drug Administration (FDA) for its newly announced hypertension notification feature on select smartwatches. Introduced during the company’s Sept. 9 event, the feature uses an algorithm to analyze data from the optical heart sensor every 30 days, evaluating how blood vessels respond to heartbeats. If the watch detects signs consistent with hypertension, it will notify the user.
Apple explained that the feature was built using machine learning and training data from studies involving more than 100,000 participants, and its performance was validated in a clinical study with over 2,000 participants. While it will not detect all cases of hypertension, the company expects it could alert more than one million people to possible undiagnosed high blood pressure within the first year. The feature will be available on Apple Watch Series 9, 10, and 11, as well as Watch Ultra 2 and Ultra 3 models running watchOS 26, and will roll out before the end of September in more than 150 countries, including the U.S. and European Union.
This clearance adds to Apple’s growing portfolio of FDA-authorized health technologies. Earlier this year, the company received clearance for its Digital Prism Correction Feature, which provides image adjustments in Apple Vision Pro for users with prism eyeglass prescriptions. In 2023, Apple gained clearance for its sleep apnea detection tool on Apple Watch, as well as an over-the-counter hearing aid function in its AirPods Pro that uses machine learning to adapt sound to users’ hearing needs after a brief test. The company has also secured clearance for its Irregular Rhythm Notification Feature, which detects irregular heart rhythms suggestive of atrial fibrillation in adults.
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