New Apple Watch Includes Built-in ECG

The latest iteration of the Apple (Cupertino, CA, USA) Watch, the Series 4, includes an electrocardiogram (ECG) sensor, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. The new smartwatch was revealed at the recent September 2018. Apple iPhone launch event.

To obtain an ECG, users touch and hold the side of the watch while it sends an electric current through the chest to the opposite hand; after 30 seconds, the device measures heart rhythms using electrodes built into the back of the sapphire crystal and the digital crown. The sensor classifies them, alerting the user if there are signs of atrial fibrillation (AF). The watch also intermittently analyzes heartbeats in the background for irregularities, or if pulse exceeds or falls below a specified threshold. All data recordings and any noted symptoms are stored in the watch’s Health app in a PDF file format that can be shared with physicians.

Additional health features include fall detection, which works by analyzing wrist trajectory and impact acceleration. If needed, the Watch will initiate an emergency call. If it senses the user is immobile for one minute, it will automatically call and send a message to emergency contacts using the native SOS feature. Other improvements include enhanced fitness and health tracking, walkie-talkie mode, a breath feature to guide breathing for meditation, and more. An app unlocking the wrist-based ECG functionality will be available to consumers in the United States in late 2018.

“We’re thrilled Apple Watch has become an essential part of people's lives,” said Jeff Williams, chief operating officer at Apple. “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 detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health.”

“We’re enthused by what we see currently happening in digital health. Recent product approvals and clearances have given consumers and providers access to powerful technologies that have the potential to advance the delivery of health care,” commented FDA Commissioner Scott Gottlieb, MD. “We know that our actions will help encourage the development of incredibly innovative products. We hope to see health care adopting more and more disruptive technologies that positively impact people’s lives.”

While retaining its original design, the fourth-generation Apple Watch includes a 30% larger display, which is seamlessly integrated into a thinner, smaller case, with a new user interface that provides more information with richer detail. The Series 4 runs on watchOS 5, which provides advanced activity and communications features, a new accelerometer and gyroscope which measures up to 32 g forces, and an electrical heart rate sensor that has been granted a De Novo classification by the U.S. Food and Drug Administration (FDA) as a Class II medical device.

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