Particle.news

Download on the App Store

FDA Clears Apple Watch Hypertension Alerts, Rolling Out With watchOS 26 on Sept. 15

Apple frames the passive 30‑day trend detector as an early warning that requires cuff confirmation with a clinician’s review.

Overview

  • The feature will ship in watchOS 26 to Apple Watch Series 9, 10, and 11 and Apple Watch Ultra 2 and 3, with SE models not supported.
  • Availability begins next week in more than 150 countries and regions, with some markets contingent on local regulatory clearance.
  • Using the optical heart sensor, the watch analyzes blood‑flow patterns over rolling 30‑day periods to flag signs consistent with chronic high blood pressure.
  • Apple instructs users who receive an alert to log seven days of readings with a validated cuff and share results with a healthcare provider in line with AHA guidance.
  • Apple reports training data from over 100,000 participants, clinical validation in studies of more than 2,000 people, 95.3% specificity, and a projection to alert over 1 million undiagnosed users in the first year.