January 26, 2016 — Conavi Medical Inc. (formerly Colibri Technologies Inc.) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Foresight ICE System. The system is cleared for intracardiac and intraluminal ultrasound visualization of cardiac and great vessel anatomy, as well as visualization of other devices in the heart and great vessels of patients.
The Foresight ICE System is the first catheter-based ultrasound system capable of providing both 2-D and 3-D ultrasound images of cardiac anatomy around the circumference of the catheter's tip. The system includes the dual-display Conavi Hummingbird imaging console and the Foresight ICE catheter. These products can be used to support a growing number of minimally invasive cardiovascular procedures performed in the United States, such as ablations and other procedures that may require access to targeted regions of the heart.
For more information: www.colibritech.com