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Apple Watch Series 4 is first consumer device to receive FDA clearance for ECG monitoring



 

The Apple Watch Series 4 has received clearance from the U.S. Food and Drug Administration to operate as an over-the-counter ECG-monitoring device, becoming the first device available to consumers over the counter to offer the functionality.

Confirmed on-stage at Apple’s September event, the approval from the FDA for the Apple Watch’s electrocardiogram functionality makes it one of the only devices on the market to provide its users EKG readings. Typically ECG devices are not available for purchase by consumers, making the Apple Watch Series 4 an exception.

Apple has been pushing its Apple Watch to become a more useful device for healthcare, and has worked with the FDA about its ambitions. The company has previously talked to the head of the FDA about “mobile medical applications” in 2014, while in 2017 it was picked to join eight other companies in an FDA pilot program to avoid problematic regulations that could slow down the development of new health-related products.

The new Apple Watch now has electrodes in the sapphire crystal and digital crown, allowing users to take an ECG at any time using the included app. All ECG recordings are stored in the Health app, and can be shared with healthcare professionals at a later time.

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.





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