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Adam Masin Discusses FDA "DeNovo" Classification for ECG App in New Apple Watch

WIRED

September 14, 2018

In “The ECG in the new Apple Watch is a potential healthcare headache,” an article published in WIRED, Adam Masin explains the significance of a “de novo” classification with respect to medical devices sold in the United States. Apple reports that its Watch Series 4 includes an electrical heart rate sensor designed to take an electrocardiogram (ECG) using the new ECG app.

To read the full article, click here.

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