The Apple Watch atrial fibrillation (AFib) history feature has been qualified by the FDA under its Medical Device Development Tools (MDDT) program.
According to the FDA, the Afib 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.
AFib, is responsible for about 130,000 deaths and 750,000 hospitalizations each year in the U.S. Up to 30% of cases go undiagnosed until life-threatening complications occur. Worldwide, about 33 million people have the condition.
