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FDA Qualifies Apple’s AFib History feature as an MDDT
The FDA today announced that it has qualified the Apple Watch AFib ( Atrial Fibrillation) history feature as an MDDT (Medical Device Development Tools). Apple’s Afib history feature becomes the first digital health technology qualified under MDDT to provide a non-invasive way to check estimates of AFib burden. The Afib History feature analyzes pulse rate […]
Tools such as biomarker tests, clinician-reported outcome measures, or computational models, and digital health technologies like sensors or wearables, play an important role in helping the FDA understand how medical devices work, in terms of safety, effectiveness, and other aspects of performance. The first digital health technology qualified under the MDDT program, providing a non-invasive way to check estimates of atrial fibrillation (AFib) burden within clinical studies. I am a technologist with years of experience with Apple and wearOS products, have a BS in Computer Science and an MBA specializing in emerging tech, and owned the popular site AppleToolBox.
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