Novel ICE System for Intracardiac Echocardiography Receives US FDA Clearance

A novel catheter-based ultrasound system that provides ultrasound images of cardiac anatomy around the tip of the catheter has received US Food and Drug Administration (FDA) 510(k) clearance.

The system is intended for use in intracardiac and intraluminal ultrasound imaging of the anatomy of the heart and associated great vessel anatomy. The system is the first catheter-based ultrasound system that can provide both 2D and 3D images of cardiac anatomy around the catheter’s tip.

The Foresight ICE system is made by Conavi Medical, formerly Colibri Technologies (Toronto, Canada), and includes Conavi’s dual-display Hummingbird imaging console, and the Foresight ICE catheter. The system supports minimally invasive cardiovascular procedures, for example ablations, that may require access to targeted areas of the heart.

"FDA clearance of the Foresight ICE System represents a major milestone for Conavi's team and our customers in the US healthcare system," says Brian Courtney, CEO of Conavi Medical Inc. "We look forward to working with physicians in the United States by providing them with new visualization tools to support existing and emerging minimally invasive procedures for patients with a broad range of cardiac conditions. The Foresight ICE system represents Conavi's lead product in its commercialization pipeline. The advanced technology in this system provides us with a remarkable platform from which we will be able to expand in the future to help physicians, healthcare systems, and industry partners better address a large number of clinical needs."

Related Links:
Conavi Medical (Colibri Technologies)