Apple gets clearance from FDA for Watch Series 4’s EKG and irregular heart beat apps

Aurel Dragan 28/09/2018 | 08:51

Apple announced that the US Food and Drug Administration cleared two new features for the Apple Watch Series 4. One is an advanced method of monitoring the heart called an electrocardiogram (EKG) and the other is the ability to detect and notify the user of an irregular heart rhythm. Both features will be available in the device later this year.

However, FDA notes that the features are not intended to be used by people under the age of 22. Also, the irregular rhythm is not intended for people who have previously been diagnosed with atrial fibrillation, the most common causes of an irregular rhythm. Which means that it should be used by healthy people.

Also, FDA specify that the apps are not intended to replace traditional methods of diagnosis or treatment. They might provide extra information, but they will not replace a visit to the doctor.

As The Verge notes, the FDA clearance is not the same as approving them. The FDA rules are on different classes and approval is on Class III, while Class II and Class I only gives clearance. Apple Watch in on Class II.

Still, this is a winner for Apple as it is the first smart-watch with this classification. Apple Watch Series 4 was launched at the last event the company held and will be on the market in the coming weeks.

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