Apple has officially received FDA clearance for its new hypertension notifications feature on Apple Watch, a major step forward in expanding its health monitoring capabilities. The feature was announced earlier this week alongside Apple Watch Series 11 and Apple Watch Ultra 3, with the company saying it was awaiting regulatory approval in the United States. That approval has now arrived, and Apple confirmed that the rollout will begin next week.
As reported by 9to5Mac, the feature has received FDA clearance which means that the hypertension notifications will be available in over 150 countries and regions, including the US, EU, Hong Kong, and New Zealand. This wide availability underscores Apple’s strategy of making health insights accessible to a global audience. Unlike traditional blood pressure monitors, the Apple Watch feature uses the optical heart sensor to passively analyze vascular responses and look for consistent patterns that may indicate hypertension over a 30-day period.
Apple explains that the system is not a formal diagnostic tool, but rather a background process designed to raise awareness. In testing, it achieved 95.3% specificity in the Normal category. The company highlights that the alerts could reach nearly half of people with high blood pressure, with even greater accuracy for those in the Stage 2 hypertension category. By flagging potential concerns, Apple expects the feature could notify over one million people with undiagnosed hypertension in its first year.
The new notifications will be supported on Apple Watch Series 11, Apple Watch Ultra 3, Apple Watch Series 9, Apple Watch Series 10, and Apple Watch Ultra 2. This ensures that both current and recent watch owners can take advantage of the technology without needing the very latest hardware.
Hypertension is a critical health issue linked to long-term risks such as heart disease, stroke, and kidney damage. Apple’s approach focuses on awareness and early intervention by encouraging users to discuss potential risks with their doctors. With the FDA’s green light, Apple Watch is positioned to become an even more important tool in preventative healthcare, offering users valuable insights that may help them adopt healthier habits or seek treatment before conditions worsen.
