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

If your email program has trouble displaying this email, view as a webpage.

U.S. Food and Drug Administration, Center for Devices and Radiological Health

FDA Qualifies Apple Atrial Fibrillation History Feature as an MDDT

A conceptual image of a human body superimposed over a doctor.

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.

Manage Subscriptions | Unsubscribe All | Help