FDA greenlights sleep apnea detection on new Apple Watch

The Food and Drug Administration (FDA) has approved Apple’s new sleep apnea detection feature on three of its latest watch models, the company confirmed Monday.

The feature — available for the Apple Watch Series 9, Series 10, and Ultra 2 — uses the watch’s accelerometer to monitor a user’s “breathing disturbances” while they are sleeping. Users can view these tracked disturbances in their Health app, which classifies the levels as elevated or not elevated, according to Apple.

Dubbing it “Breathing Disturbances,” Apple announced the feature last week during its annual hardware event. It had not been approved by the FDA at the time of the announcement.

A spokesperson for the FDA confirmed to The Hill on Monday the agency has since greenlighted the health feature.

According to the agency’s approval notice, the feature is not intended to give a stand-alone diagnosis or replace traditional methods of diagnosis but rather will assess a user’s risk of sleep apnea.

An estimated 39 million adults in the U.S. experience obstructive sleep apnea, a disorder that causes breathing to be interrupted and repeatedly stop and start, according to the National Council on Aging.

The disorder can cause daytime exhaustion, mood changes, headaches and night sweats, according to the Cleveland Clinic. Complications include high blood pressure or heart issues, Type 2 diabetes and liver issues. 

The new feature will be available in more than 150 countries and regions this month, Apple said last week. It was rolled out alongside a series of other new health-related features for Apple products.

Apple’s new AirPods Pro 2 model will double as a “clinical grade” hearing test and professional grade hearing aid for iPhone and iPad users. The tech giant claimed it is the world’s first software-enabled hearing aid feature, which was approved by the FDA three days after the hardware event.

Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, said it “advances the availability and acceptability of hearing support for adults with perceived mild to moderate hearing loss.”

The California-based company also unveiled its newest iPhone 16 lineup last week, stating the model was built “from the ground up” for Apple’s native artificial intelligence software, “Apple Intelligence.”

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