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Apple Watch's ECG app: Here's what US FDA's clearance actually means

Updated : September 17, 2018 06:39 AM IST

In the clearance, the regulator, with regard to the ECG app, said that “this device is not intended to provide a diagnosis,” which means that it cannot be used as a replacement for existing medical equipment.
Similar observations on the irregular rhythm notification feature were taken by the FDA.
Both the features are only intended for over-the-counter (OTC) use.
Apple Watch's ECG app: Here's what US FDA's clearance actually means
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