Apple Watch Receives FDA Approval for Hypertension Detection Feature

The US FDA has cleared Apple to roll out a hypertension detection feature on some of its smartwatches, including the Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models. The feature uses the optical heart sensor to analyze blood vessel responses to heartbeats and may alert users about a million cases of high blood pressure. It will be available in 150 countries and regions before the end of September.

The U.S. Food and Drug Administration (FDA) has approved Apple's new hypertension detection feature for certain models of its smartwatches. The feature, which uses the optical heart sensor to analyze blood vessel responses to heartbeats, is expected to alert users to potential high blood pressure. The FDA approval follows Apple's unveiling of the feature at its September 9 event, where it also introduced a refreshed iPhone lineup.

The hypertension alert feature will be available on Apple Watch Series 9, Series 10, Series 11, and the premium Ultra 2 and Ultra 3 models before the end of September. Apple plans to make the feature accessible in around 150 countries and regions, including the United States and the European Union US FDA clears Apple Watch feature rollout for hypertension detection^[1].

Using the optical heart sensor, the feature operates passively, reviewing data over a 30-day period. It notifies users if it identifies consistent indications of high blood pressure. While the feature may not detect all cases of hypertension, Apple estimates it could provide alerts to approximately one million users US FDA approves Apple Watch hypertension detection feature^[2].

The feature's rollout is significant for public health, as it could help millions of people monitor their blood pressure more effectively. However, it's important to note that while the feature can provide useful insights, it should not replace professional medical advice.