FDA Update: Agency Qualifies Apple AFib History Feature as an MDDT

The U.S. Food and Drug Administration (FDA) announced on May 1 that the Apple Atrial Fibrillation (AFib) History Feature now qualifies as a Medical Device Development Tool (MDDT) to assess AFib burden estimates within clinical studies.

This is the first digital health technology to qualify under the agency’s MDDT program for providing a noninvasive means of checking AFib burden estimates within clinical studies.

According to the FDA, the Apple AFib History Feature can “be used as a biomarker test…as a secondary effectiveness endpoint within clinical studies to evaluate the safety and effectiveness of cardiac ablation devices” and can be used throughout the clinical study, both before and after intervention, as a way to estimate a study participant’s weekly AFib burden.

For more on the MDDT program, visit the FDA website.

Clinical Topics: Arrhythmias and Clinical EP, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: United States Food and Drug Administration, Atrial Fibrillation, ACC Advocacy

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