New FDA-Approved Apple Watch Performs ECG, Detects AF

By David Costill
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Apple recently announced that its new Apple Watch Series 4 is the first over-the-counter consumer device that can perform electrocardiogram (ECG) testing and detect atrial fibrillation (AF).

The Apple Watch Series 4 is also the first FDA-approved device that was approved through a new De Novo classification pathway, according to an Apple press statement.

“The FDA worked closely with [Apple] as they developed and tested these software products, which may help millions of users identify health concerns more quickly,” Scott Gottlieb, MD, commissioner of the FDA, said in a press statement. “Health care products on ubiquitous devices, like smart watches, may help users seek treatment earlier and will truly empower them with more information about their health.”

Apple Campus. Flikr.

The new smart watch allows customers to take an immediate ECG test on their wrist and present that data to their primary care physician or cardiologist. The test results, and other health care information, are stored in HIPPA-compliant PDF files. This ECG test can be used to measure for rapid heart rate that leads to stroke, heart failure, or other cardiovascular (CV) complications.

According to Apple, the smart watch also has an app that continuously monitors heart rate in order to detect early signs of AF. The watch alerts patients if their heart has an irregular rhythm or if heart rate falls below an acceptable threshold—a sign of AF.

“With the addition of groundbreaking features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health,” Jeff Williams, CEO of Apple, said in a press release.

Furthermore, the smart watch has been endorsed by the American Heart Association (AHA). Ivor J. Benjamin, MD, president of the AHA, said explained during Apple press event, that having access to data for symptoms that are often not present during a physical exam will help physicians to detect CV issues faster and more efficiently.

“I’m inspired by the live-saving potential of technology and applaud Apple’s innovation and commitment to health,” Benjamin said. “Capturing meaningful data about a person’s heart, in real-time, is changing the way we practice medicine. The ability to access health data on an on-demand ECG is game-changing, especially when evaluating AF."

A noncellular version will be available for $399, while a cellular-compatible version will cost $499 — both will be released on September 21.

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