Apple Watch Series 11 Now FDA-Approved for Detecting Silent Killer Hypertension

Global health experts estimate that nearly 1.3 billion adults worldwide suffer from hypertension, often called the “silent killer” because it can develop unnoticed for years. Many individuals remain unaware of their high blood pressure, increasing their risk of heart attacks, strokes, and kidney disease. In a groundbreaking move, Apple has announced that its latest smartwatch, the Series 11, now includes FDA-cleared hypertension detection capabilities, potentially transforming early diagnosis and prevention efforts.

Revolutionary Health Monitoring on Your Wrist

Starting next week, users across more than 150 regions—including the United States, European Union nations, Hong Kong, and New Zealand—will gain access to the new hypertension alerts through watchOS 26. Compatible devices include the Apple Watch Series 9 and newer models, as well as the Apple Watch Ultra 2 and beyond. This feature leverages the watch’s optical heart sensor to passively monitor blood vessel responses over a 30-day period, without the need for manual blood pressure measurements.

By analyzing photoplethysmography (PPG) signals—the changes in blood volume under the skin—the device detects patterns indicative of chronic hypertension. If consistent signs are observed, users receive a notification prompting them to consult a healthcare professional. Apple anticipates that over 1 million people with undiagnosed hypertension could benefit from this early warning system within its first year of release.

Built on Extensive Research and Validation

Apple’s new feature is the result of years of dedicated health research, building on existing tools like ECG and irregular rhythm notifications. A comprehensive clinical validation involved more than 2,000 participants wearing the watch alongside traditional cuff-based blood pressure measurements. The study demonstrated that the technology achieved over 92% specificity, significantly reducing false positives, and effectively identified more than half of individuals with Stage 2 hypertension—the most dangerous form of high blood pressure.

Importantly, the validation confirmed consistent accuracy across different ages, genders, races, and skin tones, ensuring reliability for Apple’s diverse global user base. The feature operates seamlessly in the background, providing passive monitoring that can alert users to potential health issues they might otherwise overlook.

Expert Opinions and Future Implications

Renowned cardiologist Dr. Harlan Krumholz from Yale University praises the innovation, stating, “This feature automatically flags signals that suggest high blood pressure, encouraging users to seek medical advice. It’s a critical step toward early detection, especially for those who remain undiagnosed for years.” While emphasizing that the watch is not a replacement for professional healthcare, he highlights its potential to empower users to take charge of their health and facilitate earlier interventions.

How to Enable and Use the New Feature

To activate hypertension notifications, users with compatible Apple Watch models need to update their device to watchOS 26 and enable the feature within the Health app settings. Once activated, the watch will continuously analyze blood vessel responses during waking hours, providing valuable insights without any calibration or direct blood pressure measurements.

Preorders for the Apple Watch Series 11 start at $399, with in-store availability beginning September 19. The lineup includes the flagship Series 11, featuring FDA-cleared hypertension alerts, alongside the more rugged Apple Watch Ultra 3, designed for outdoor enthusiasts and athletes, also equipped with the new health monitoring capabilities.

The Next Step in Wearable Healthcare

With FDA approval now secured, Apple Watch is evolving from a fitness tracker into a vital health monitoring device capable of detecting serious conditions early. While not a substitute for regular medical care, the smartwatch offers an additional safety layer, especially for individuals who rarely visit healthcare providers. As wearable technology continues advancing, it promises a future where early detection can save countless lives from silent, deadly conditions.

Ethan Cole

Ethan Cole

I'm Ethan Cole, a tech journalist with a passion for uncovering the stories behind innovation. I write about emerging technologies, startups, and the digital trends shaping our future. Read me on x.com