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Apple Watch Atrial Fibrillation Tracking History Software Gets FDA Clearance

June 9, 2022

Apple has received the FDA’s 510(k) clearance for a new feature on its Apple Watch, OS 9 operating system for tracking patients with atrial fibrillation (AFib).

In the newly cleared software version, users who are diagnosed with AFib can turn on the FDA-cleared AFib History feature and access information including an estimate of how frequently their heart rhythm shows signs of AFib.

Users will also receive weekly notifications, including lifestyle factors that may influence AFib, like sleep, alcohol consumption and exercise. Users will be able to download a PDF with a detailed history of their AFib and lifestyle factors, which can be shared with healthcare providers.

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