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.

Tim Casey,

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.

Around the web

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Philips introduced a new CT system at ECR aimed at the rapidly growing cardiac CT market, incorporating numerous AI features to optimize workflow and image quality.

Trimed Popup
Trimed Popup