FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias

Acutus Medical (a US-based heart rhythm technology company) announced that the U.S. Food and Drug Administration has cleared the AcQMap High Resolution Imaging and Mapping System and the AcQMap 3D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The Company plans to introduce initial commercial systems to U.S. customers in early 2018.

"This clearance will allow electrophysiologists (EP's) in the United States access to a new technology that uses ultrasound to visualize cardiac anatomy and dipole density to map the pathway of every heartbeat.  The System can also be used with existing commercially available cardiac ablation platforms," said Steven McQuillan, Senior Vice President, Regulatory and Clinical Affairs, for Acutus Medical. "The AcQMap System was designed in close collaboration with some of the most respected names in the field to provide practitioners with a suite of tools that enables them to rapidly map and re-map to visualize changes throughout the ablation procedure. We firmly believe that by working together with EP practitioners and scientists, we will continue to uncover breakthrough innovations to improve and advance cardiac care."