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Medical Devices / Submissions and Approvals

Apple Watch Heart Rhythm App Earns CE Mark

April 1, 2019
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Apple received a CE Mark for an ECG app for use in the latest Apple watch, allowing  users to take an electrocardiogram right from their wrist.

The app can record the heart rhythm when users experience symptoms such as a rapid or skipped heart beat and provide clinically important data to physicians.

The watch’s irregular rhythm notification feature occasionally checks heart rhythm in the background and sends a notification if an irregular heart rhythm that appears to be atrial fibrillation is identified.

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