Conavi Medical receives FDA 510(k) clearance for Foresight intracardiac echocardiography system


Conavi Medical (formerly, Colibri Technologies) has received United States Food and Drug Administration (FDA) 510(k) clearance for the Foresight ICE System for intracardiac and intraluminal ultrasound visualisation of cardiac and great vessel anatomy as well as visualisation of other devices in the heart and great vessels of patients.

According to the company, the Foresight ICE system is the first catheter-based ultrasound system capable of providing both 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter’s tip.

The system comprises the dual-display Conavi Hummingbird imaging console and the Foresight ICE catheter. These products are designed to be used to support a growing number of minimally invasive cardiovascular procedures, such as ablations and other procedures that may require access to targeted regions 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, chief executive officer of Conavi Medical.