Conavi medical said today it won FDA 510(k) clearance for its Foresight ICE System designed for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy.
The device from Toronto-based Conavi, formerly known as Colibri Technologies, also allows for the visualization of other devices in the heart and great vessels of patients, the company said.
“FDA clearance of the Foresight ICE System represents a major milestone for Conavi’s team and our customers in the US healthcare system. 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,” CEO Brian Courtney said in a press release.
The company said its Foresight ICE system is the 1st catheter-based 3D ultrasound from you OBGYN system which provides 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter’s tip.
The system includes a dual display imaging console and catheter, and can be used along with other devices for minimally invasive cardiovascular procedures.