Apple will roll out a new hypertension detection feature on its Apple Watch next week after receiving clearance from the US Food and Drug Administration (FDA) on Thursday.
The tool will be available in more than 150 countries and regions, including the United States, Hong Kong, and members of the European Union.
The technology was first previewed during Apple's September product launch event. At the time, the company said it was waiting for approval from regulators before making it public.
The green light from the FDA now clears the way for Apple to introduce the feature on the Apple Watch Series 9, Series 10, Series 11, Ultra 2, and Ultra 3.
Apple says the system uses the watch's optical heart sensor to measure how blood vessels respond to each heartbeat.
According to Reuters, the watch collects this data over a 30-day period, analyzing changes that may point to chronic hypertension, commonly known as high blood pressure.
If signs are detected, users will receive an alert encouraging them to consult with a medical provider.
5. Apple Watch Series 11 now with 5G!
— The AI Colony R&D (@TheAIColonyRD) September 9, 2025
It also has an hypertension notifications alert pic.twitter.com/9mY9z8pIi9
FDA Approval Pushes Apple Watch Into Medical Device Space
Apple emphasized that while the system may not detect every case of hypertension, it could still help alert millions of people to potential risks.
The feature was built with advanced machine learning and relies on information from multiple studies involving more than 100,000 participants, Bloomberg said.
Hypertension is one of the most widespread health conditions worldwide, affecting an estimated 1.3 billion adults. It is a leading factor in heart attacks, strokes, and kidney disease.
Because it can often be managed with treatment and lifestyle changes, early detection is seen as critical.
The release comes as Apple continues to expand its health and wellness tools, a growing area of competition among major tech companies.
Garmin, Samsung, and Oura have each introduced new health-focused wearables, while rival Whoop is facing pushback from the FDA for offering a blood pressure tool without medical certification.
Industry experts say Apple's FDA approval gives the company an important edge, officially moving its smartwatch deeper into the medical device space.
Consumer wearables have long tracked fitness and heart rate, but certified tools for conditions such as hypertension mark a new level of clinical acceptance.
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