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.