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.
May 02, 2024
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