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Apple Watch Series 11 receives FDA clearance for hypertension alerts
Apple Watch Series 11 receives FDA clearance for hypertension alerts

Apple's Awe Dropping event started with dramatic health testimonials from Apple Watch users, then revealed a key new feature for the new Watch Series 11: hypertension alerts. The function had yet to receive FDA clearance at the time, but that has now been granted, as first reported by Bloomberg and confirmed by Apple. As a result, it will reportedly be available to users in 150 countries when the Watch 11 and Ultra Watch 3 ship starting on September 19. 
Hypertension alerts can help detect hypertension (high blood pressure), a potentially dangerous condition that affects over a billion people. The feature relies on the Watch's optical heart sensor, but now uses new machine learning algorithm that also draws from a study involving more than 100,000 participants to look for high blood pressure. It works in the background a month-long period to seek patterns associated with hypertension. Unlike devices that measure your specific blood pressure, it only tells users that there may be a danger. 
Last year, Apple received FDA clearance for its over-the-counter Hearing Aid function that transforms the second-gen AirPods Pro into OTC hearing aids for people with mild-to-moderate hearing loss. Another recently approved feature is sleep apnea detection. However, the company is currently facing a lawsuit over the Apple Watch's redesigned blood oxygen monitoring feature.  
Correction, September 15, 2025, 10:27AM ET: This article and its headline originally stated that the Apple Watch received FDA approval for the new hypertension alerts feature. It received FDA clearance, which is a lower level of authorization compared to FDA approval. We apologize for this error.This article originally appeared on Engadget at https://www.engadget.com/wearables/apple-watch-series-11-receives-fda-clearance-for-hypertension-alerts-120046138.html?src=rss

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