Apple Watch Series 11 Gains FDA Clearance for Hypertension Alert Feature
The newly announced Apple Watch Series 11 and Ultra Watch 3 will now include a key health feature at launch. Apple has received FDA clearance for its new hypertension alerts function, which will be available to users in 150 countries when the devices begin shipping on September 19.
This development follows the feature’s initial unveiling at a recent Apple event, where it was showcased alongside dramatic testimonials from Apple Watch users about the device’s impact on their health. At the time of the announcement, the hypertension detection capability was still awaiting regulatory clearance.
The feature is designed to help detect hypertension, also known as high blood pressure, a condition affecting over a billion people globally and a significant risk factor for serious health complications. It operates by utilizing the Watch’s existing optical heart sensor in conjunction with a new machine learning algorithm. This algorithm was developed using data from a large-scale study involving more than 100,000 participants.
Unlike a traditional blood pressure monitor that provides a specific systolic and diastolic reading, the Apple Watch’s system works in the background over a month-long period. It analyzes data patterns to look for signs associated with hypertension. The watch will not display a blood pressure measurement. Instead, it will alert a user that it has detected a pattern consistent with high blood pressure, suggesting they may want to consult with a healthcare professional for a definitive diagnosis using validated medical equipment.
This is not Apple’s first foray into receiving FDA clearance for health-related features on its devices. Last year, the company received clearance for an over-the-counter Hearing Aid function that allows second-generation AirPods Pro to act as hearing aids for individuals with mild-to-moderate hearing loss. More recently, Apple also gained clearance for a sleep apnea detection feature on its watches.
However, the company continues to navigate a complex regulatory and legal landscape for its health technology. It is currently involved in an ongoing lawsuit concerning the redesigned blood oxygen monitoring feature on its watches.
A correction was issued regarding the level of authorization from the FDA, clarifying that the feature received FDA clearance, which is a different and generally lower level of regulatory authorization compared to a full FDA approval.
The addition of hypertension alerts represents another significant step for Apple in its long-term strategy to position the Apple Watch as a comprehensive health and wellness device, providing users with proactive insights into their well-being.
