Apple Watch#39;s ECG app: Here#39;s what US FDA#39;s clearance actually means

September 14
16:56 2018

With tech major Apple announcing that the US Food and Drug Administration (FDA) had cleared Apple Watch’s advanced method of electrocardiogram (ECG) and its ability to detect and notify the user of an irregular heart rhythm, the drug regulator’s approval may have been misinterpreted.

The drug regulator said that it has classified the Watch as a Class II device, which means that the regulator has not ‘approved’ the device for medical usage but has given a clearance.

In the clearance, the regulator said, “This device is not intended to provide a diagnosis.” This means that it cannot be used as a replacement for existing medical equipment.

The drug regulator said that the ECG app is intended for over-the-counter (OTC) use and the data that is displayed on the app is intended for informational use only.

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“The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment,” the regulator said.

The regulator has also said that the app is not intended for use for people under the age of 22.

Similar observations on the irregular rhythm notification feature were taken by the FDA.

The regulator, in its notification, said that the irregular rhythm feature is also intended for over-the-counter (OTC) use and it is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib.

AFib stands for Atrial fibrillation, which “is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications,” according to the American Heart Association.

“The absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still,” FDA said in its clearance to Apple.


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