U.S. FDA approves Apple Watch high blood pressure detection
The Apple Watch’s hypertension, or high blood pressure, detection system, cleared by the U.S. FDA on Thursday, will launch next week. Unveiled at Apple’s early September product event, the feature will be available in 150 countries and regions, including the U.S., Hong Kong, and the EU.
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Hypertension notifications on Apple Watch use data from the optical heart sensor to analyze how a user’s blood vessels respond to the beats of the heart. The algorithm works passively in the background reviewing data over 30-day periods, and will notify users if it detects consistent signs of hypertension. These notifications provide users with valuable insights into their health as it relates to this widespread condition simply by wearing their Apple Watch, so they can begin making potentially lifesaving behavioral changes, or start treatment to reduce their risk of serious, long-term health events.
Like all of Apple’s health features, hypertension notifications are grounded in rigorous scientific validation. The feature was developed with advanced machine learning and training data from multiple studies totaling over 100,000 participants. Its performance was then validated in a clinical study of over 2,000 participants. While hypertension notifications will not detect all instances of hypertension, with the reach of Apple Watch, the feature is expected to notify over 1 million people with undiagnosed hypertension within the first year.
“Hypertension is the leading preventable cause of heart attack and stroke, yet millions remain undiagnosed,” said Harlan Krumholz, MD, SM, cardiologist and scientist at Yale University and Yale New Haven Hospital, in a statment. “Making accurate detection easy and part of daily life can help people get care earlier and prevent avoidable harm.”
If users receive a hypertension notification, it is recommended that they log their blood pressure for seven days using a third-party blood pressure cuff and share the results with their provider at their next visit, which is consistent with the latest American Heart Association guidelines for the diagnosis and management of hypertension.
Hypertension detection will be available on the Apple Watch Series 9, Series 10, Series 11, Ultra 2, and Ultra 3 running watchOS 26 and later.
The tool will use data from the Apple Watch’s optical heart sensor to analyze how a user’s blood vessels respond to heartbeats over a 30-day time period, according to Apple. The user will be notified if any signs of chronic hypertension, or high blood pressure, are detected and encouraged to share results with a medical provider.
About 1.3 billion adults worldwide are affected by hypertension, a primary risk factor for stroke, heart attack, and kidney disease that can often be modified with lifestyle and medical interventions…
Whoop Inc., the maker of screen-less fitness bands, is actively pushing back on demands from the FDA to disable its own blood pressure tracking tool. The FDA said the new Whoop MG tracker — short for medical grade — is operating as a medical device but doesn’t have certification for blood pressure tracking.
Samantha Kelly for Bloomberg News
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