By Clinical Informatics News Staff

September 12, 2018 | Today Apple introduced the Apple Watch Series 4, which the company announced has received approval from the US Food and Drug Administration (FDA) to include electrocardiogram (ECG) functionality, making it the first over-the-counter device to offer the capability. The news was confirmed on-stage during the company’s September event.

“Apple Watch Series 4 enables customers to take an ECG reading right from the wrist using the new ECG app, which takes advantage of the electrodes built into the Digital Crown and new electrical heart rate sensor in the back crystal,” an Apple representative said in the company’s official press release. “With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification. It can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications.”

All recordings, their associated classifications, and any noted symptoms are stored in the Health app in a PDF that can be shared with physicians, the company reported.

This is not the first time the tech company has waded into the waters of healthcare, having launched the Apple Heart Study app, a study using Apple Watch’s heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing AFib, last year.

The ECG functionality will be available at first to customers in the United States, with Apple also working to bring the feature to other markets at a later time.