FDA clears Medtronic’s CardioInsight Noninvasive 3D Mapping System

cardiac-mapping vest

The CardioInsight system creates 3D electroanatomic maps of the heart by collecting electrocardiogram (ECG) signals from the chest, and combining these signals with data from a computed tomography (CT) scan of the heart. This is the first commercially released, noninvasive, cardiac electrical mapping system in the world, eliminating the invasive steps of this clinical procedure. It uses a 252-electrode sensor vest that is worn by the patient to pair body surface electrical data with heart-torso anatomy. Medtronic will employ a strategic rollout of the technology in the geographies where it is cleared. In the meantime, CardioInsight was first used commercially in the U.S. by Vivek Reddy, M.D., director of cardiac arrhythmia services at the Mount Sinai Hospital and the Mount Sinai Health System, New York.