Apple Watch Series 11 Gets FDA Clearance for Hypertension Alerts

Apple has received FDA clearance for its new hypertension alerts, which will ship with the Apple Watch Series 11 and Apple Watch Ultra 3 starting Sept 19 and will be available in 150+ countries. The feature runs in the background to look for patterns associated with high blood pressure using the Watch’s optical heart sensor combined with a new machine-learning model trained on a study of over 100,000 participants.

How it works

• Uses the optical heart sensor + ML to detect patterns that may indicate hypertension.
• Runs passively over time (about a month) to identify risk signals — it does not provide a specific blood pressure measurement.
• Sends an alert if it detects signs that suggest possible high blood pressure so users can seek clinical follow-up.

Availability

Ship date for Series 11 and Ultra 3: Sept 19. The feature will be available in over 150 countries and on supported recent Apple Watch models with the required software update.

Context

Apple has recently received other health-related clearances (over‑the‑counter hearing aid support for AirPods and sleep apnea detection). The company is also facing a lawsuit related to a redesigned blood oxygen monitoring feature.

Sources & where to learn more

• Apple Newsroom: Apple debuts Apple Watch Series 11
• MacRumors: Apple Watch hypertension alerts receive FDA clearance
• Search Apple Watch Series 11 on Amazon

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