FDA grants 510(k) clearance for CardioInsight 3D mapping system
The FDA granted a 510(k) clearance for the CardioInsight noninvasive 3D mapping system, which provides 3D maps of the heart and is used to map irregular heart rhythms.
Medtronic announced the approval on Feb. 1.
Vivek Reddy, MD, of the Mount Sinai Hospital and Mount Sinai Health System in New York, was the first doctor to use the system in the U.S., according to Medtronic.
With the system, patients wear a 252-electrode sensor vest and have their atria or ventricles continuously and simultaneously mapped. The system collects electrocardiogram signals from the heart, while patients also undergo computed tomography scans.
Medtronic acquired CardioInsight Technologies for approximately $93 million in June 2015. CardioInsight’s ecVUE system, a noninvasive cardiac system that maps electrical disorders of the heart, received FDA 510(k) clearance in November 2014.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.