Apple unveils FDA-approved ECG feature on latest watch

Apple unveiled Wednesday its fourth-generation Apple Watch, which features an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app that was granted a De Novo classification by the FDA. Jeff Williams, chief operating officer, remarked that "the completely redesigned Apple Watch Series 4 continues to be an indispensable communication and fitness companion, and now with the addition of…features, like fall detection and the first-ever ECG app offered directly to consumers, it also becomes an intelligent guardian for your health." 

Meanwhile, FDA commissioner Scott Gottlieb said that such software products "may help millions of users identify health concerns more quickly."  He added that healthcare products on universal devices may help users seek treatment earlier and will empower them with more information about their health. 

According to Apple, the latest watch allows users to take an ECG reading from the wrist using the ECG app, "which takes advantage of the electrodes built into the Digital Crown and new electrical heart rate sensor in the back crystal." With the app, users touch the Digital Crown and receive a heart rhythm classification after 30 seconds. Apple added that the app can classify if the heart is beating normally or whether there are signs of atrial fibrillation, while all recordings, their associated classifications and any noted symptoms are stored in the app and can be shared with physicians via a PDF. 

Evercore ISI analyst Ross Muken remarked this "is really a game changer as the first wearable device with this feature." Muken added that "this update really establishes the company’s increasing efforts to push the watch as a serious medical device." 

The latest watch, which also features a new accelerometer and gyroscope that are able to detect hard falls, will be launched globally on September 14, Apple said. 

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