Apple Watch Receives Clearance from FDA as an Over-the-Counter ECG-monitoring Device

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On September 12, 2018, Apple released its new Apple Watch Series 4 with a new ECG app that can take an electrocardiogram (ECG). Apple’s new Apple Watch Series 4 has been granted De Novo classification by the FDA, which allows Apple to provide its Series 4 Apple Watches as an over-the-counter ECG-monitoring device.

Jeff Williams, Apple’s chief operating officer, noted Apple’s continued desire to make Apple Watch a more useful healthcare device for the public:

“The completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of groundbreaking features, like fall protection and first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

According to Apple, Apple Watch Series 4 is designed to intermittently analyze heart rhythms in the background and look for any irregular heart rhythm, such as atrial fibrillation (AFib). If a user’s heart rate exceeds or falls below a specified threshold, Apple Watch Series 4 can generate an alert. Electrical impulses are analyzed to generate ECG waveform and to determine AFib classification, which are automatically stored in Apple Watch’s Health app.

AliveCor received FDA clearance for its KardiaBand application for use with the Apple Watch last November. KardiaBand’s press release indicates that it includes a wearable band and a monitoring system integrated to Apple Watch.

However, according to The Verge, there are some important caveats to the FDA’s grant of de novo classification. First, both the ECG app and the irregular rhythm notification feature are not intended for people under the age of 22. Second, the irregular rhythm notification feature is not intended for people who have previously been diagnosed with atrial fibrillation. Moreover, the FDA does not intend to replace existing diagnostic methods and treatments for atrial fibrillation with Apple Watch. The FDA clearly states that “the feature is not intended to replace traditional methods of diagnosis or treatment.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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