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Apple Watch Hypertension Alerts Go Live With FDA Clearance

An AI‑trained algorithm reviews a month of optical heart data to trigger prompts for cuff confirmation plus clinician follow‑up.

Overview

  • The screening feature arrives with watchOS 26 on Apple Watch Series 9 and later and Apple Watch Ultra 2 and later, requires an iPhone 11 or newer, and needs 30 days of data after setup before any notification can appear.
  • Apple says the tool is intended for users 22 or older who are not pregnant and have no prior hypertension diagnosis, and it is not available on Apple Watch SE models.
  • Upon a possible‑hypertension notification, users are guided to record morning and evening readings with a third‑party arm cuff for seven days and to discuss results with a healthcare professional.
  • Apple told Reuters the algorithm was developed using data from 100,000 study participants and validated in a 2,000‑person study, and the feature has U.S. FDA approval with rollout planned in more than 150 countries.
  • Apple estimates about one million alerts in the first year, while clinicians caution that cuffless approaches are not diagnostic, may miss cases or vary in accuracy by context and skin tone, and could drive extra demand for care.