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Apple Watch Series 11 receives FDA clearance for hypertension alerts
Apple's Watch 11 series has received FDA approval for hypertension alerts so the feature will be available when it ships on September 19.
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. 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. 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.
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