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FDA approves Apple Watch's Atrial Fibrillation (AFib) History feature as a Medical Device Development Tool (MDDT).
The FDA has approved Apple Watch's Atrial Fibrillation (AFib) History feature as a Medical Device Development Tool (MDDT), making it the first digital health technology to receive such recognition. The feature allows for non-invasive estimation of AFib burden and can be used as a biomarker test in cardiac ablation device studies. Atrial Fibrillation affects around 33 million people worldwide and is responsible for 130,000 deaths and 750,000 hospitalizations annually in the US.
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