For the first time, the U.S. Food and Drug Administration (FDA) qualified a digital technology — Apple Watch’s AFib History feature — for a special research program. AFib, or atrial fibrillation, is a type of abnormal heart beat associated with heart attacks.
Apple Watch’s AFib History now qualifies for FDA’s stringent Medical Device Development Tools (MDDT) program. The program says which tools research sponsors can choose from to help develop and evaluate medical devices.
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