FDA Clears Apple Watch Hypertension Detection Feature for Global Rollout

Apple has received clearance from the U.S. Food and Drug Administration (FDA) to launch a hypertension detection feature on select Apple Watch models. The health regulator confirmed the approval late Friday, giving Apple the green light to expand its smartwatch health capabilities.

The new feature, powered by the optical heart sensor, was introduced alongside the latest Apple Watch and iPhone lineup during Apple’s September 9 event. It will be available on Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models. Apple plans to roll out the feature globally across 150 countries and regions, including the U.S. and EU, before the end of September.

Using advanced algorithms, the smartwatch will passively monitor blood vessel responses to heartbeats over 30-day cycles. If consistent signs of hypertension are detected, users will receive a notification. While Apple notes the tool may not catch every case of high blood pressure, it is expected to alert nearly one million people who may be at risk.

This move underscores Apple’s ongoing push into digital health technology. With hypertension affecting millions worldwide and often going undetected, the new feature could help users identify early warning signs and seek medical advice.

The approval comes as Apple intensifies competition in the wearable health tech market, where rivals like Samsung and Fitbit are also introducing advanced health-tracking tools. According to Bloomberg, Apple could begin rolling out the hypertension detection feature as early as next week.

By integrating FDA-approved hypertension monitoring directly into its popular smartwatch, Apple strengthens its positioning as both a tech innovator and a health partner, providing users with actionable insights to support long-term wellness.