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FDA Clears Apple Watch Hypertension Alerts, Rollout Starts Sept. 15

FDA clearance enables a passive, machine-learning alert that flags 30‑day patterns consistent with high blood pressure for clinical follow-up.

Overview

  • Hypertension notifications arrive with watchOS 26 on Apple Watch Series 9 and later and Apple Watch Ultra 2 and later, including the new Series 11 and Ultra 3.
  • The feature is launching in more than 150 countries and regions, with availability in some markets contingent on local regulatory approvals.
  • The system uses the watch’s optical heart sensor to analyze PPG signals over rolling 30‑day windows for signs consistent with chronic hypertension.
  • Users who receive an alert are instructed to confirm readings with a cuff over seven days and consult a clinician, aligning with American Heart Association guidance.
  • Apple cites training data from over 100,000 participants, clinical validation in more than 2,000 people, a reported 95.3% specificity, and a projection of notifying over 1 million undiagnosed users in the first year.