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FDA QUALIFICATION OF A NEW MEDICAL DEVICE DEVELOPMENT TOOL

U.S. Food and Drug Administration sent this bulletin at 05/01/2024 01:23 PM EDT


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FDA QUALIFIES APPLE ATRIAL FIBRILLATION HISTORY FEATURE AS AN MDDT

The FDA is announcing the qualification of a new tool to assess atrial
fibrillation (a type of arrhythmia, or abnormal heartbeat) burden estimates
within clinical studies through the Medical Device Development Tools (MDDT)
program.

The Apple Atrial Fibrillation History Feature is:

 * 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.
 * Designed to be used as a biomarker test to help evaluate estimates of AFib
   burden as a secondary effectiveness endpoint within clinical studies intended
   to evaluate the safety and effectiveness of cardiac ablation devices to
   treat.
 * Designed to be used throughout the clinical study, both before and after
   cardiac ablation devices, to monitor a study participant’s weekly estimate of
   AFib burden.

See All Qualified Tools


QUESTIONS?

If you have questions about CDRH’s qualification of Medical Device Development
tools, email the MDDT program at mddt@fda.hhs.gov.

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