FDA clears Apple watch to detect hypertension, a first for wearables

The U.S. Food and Drug Administration has cleared Apple to roll out a hypertension detection feature on its smartwatches, giving the company the green light to launch one of the most ambitious health tools yet built into a consumer wearable.

The feature, unveiled alongside the new iPhone lineup at Apple’s September 9 event, will debut this month on the Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models. Apple said it expects to make the tool available in more than 150 countries, including the U.S. and European Union.

Unlike traditional blood pressure monitors that rely on an inflatable cuff, Apple’s system uses the watch’s optical heart sensor to track how blood vessels respond to heartbeats. The algorithm quietly reviews data collected over 30-day periods and sends an alert if it detects persistent signs of hypertension.

The company emphasized that the tool may not catch every case but could notify more than a million people of undiagnosed high blood pressure in its first year.

Why it Matters?

By embedding passive screening into a device millions already wear daily, Apple is betting it can help fill that gap.

Apple’s Health Play:

The hypertension detector adds to a growing suite of health functions on the Apple Watch, which already includes ECG monitoring, irregular heart rhythm notifications, and blood oxygen tracking. Analysts say the move underscores Apple’s push to make its smartwatch a frontline tool for preventive health — and a way to lock users more deeply into its ecosystem.

Bloomberg earlier reported the FDA clearance, saying Apple plans to begin the rollout of the feature in the coming week. Apple declined to comment.