Apple Watch series 11 receives FDA approval for hypertension alert feature, now available in 150 countries and regions worldwide
Complementing another major chronic disease risk indicator that affects over 10 billion people worldwide

At the Apple "Awe Dropping" autumn conference held recently, Apple announced thatApple Watch series 11A new algorithm-based Hypertension Alerts feature has been added. This feature has been approved by the U.S. Food and Drug Administration (FDA) and will be officially launched in 9 countries and regions around the world when Apple Watch series 19 and Apple Watch Ultra 11 are shipped in the United States and other markets on September 3.

Long-term monitoring using algorithms

Unlike traditional blood pressure cuff-based blood pressure monitoring, the Apple Watch series 11 uses a built-in optical heart rate sensor to collect data using optical technology. This data is then fed through a new machine learning algorithm, which is claimed to run continuously in the background for approximately one month. This algorithm analyzes the user's heart rate changes and related patterns, predicting potential hypertension risks. If the system detects an abnormal trend, it notifies the user to seek further medical attention to determine if there are serious consequences.

Apple notes that this feature doesn't directly display real-time blood pressure readings, but rather provides an early warning of "possible hypertension," helping users take action before the problem actually worsens. The model behind the algorithm is based on clinical study data from over 10 participants, demonstrating that its predictive accuracy meets the standards approved by the U.S. Food and Drug Administration.

Expanding the scope of health functions

In recent years, Apple has actively promoted the Apple Watch as a key health and preventative healthcare tool. Beyond the familiar heart rate monitoring, arrhythmia detection, and fall detection, last year Apple secured FDA approval for the second-generation AirPods Pro to function as over-the-counter hearing aids and introduced sleep apnea detection to the watchOS platform. This approval for a hypertension alert adds another significant risk indicator for a major chronic disease affecting over one billion people worldwide.

Still facing patent and regulatory challenges

However, Apple Watch is still not designed for blood oxygen detection.Facing infringement allegations from MasimoHowever, Apple continues to advance its health function strategy, indicating that it regards health technology as a long-term development focus. In the future, it may further integrate more physiological monitoring technologies, such as the long-rumored non-invasive blood glucose monitoring function.

Global launch and follow-up observation

With the approval of the U.S. Food and Drug Administration, Apple will enable the hypertension warning feature in 150 countries and regions around the world. For consumers, this will make the Apple Watch series 11 not just a wearable device, but also a frontier for daily health management.

What remains to be seen is whether this type of "non-real-time blood pressure monitoring" can effectively promote early diagnosis of hypertension, and whether it will prompt other wearable device manufacturers to follow suit and introduce similar features, ushering in a new wave of health monitoring competition in the wearable market.

Apple Watch series 11, Samsung Galaxy Watch7, Fitbit Sense 2 health function comparison table: