Medical device firm Conavi Medical has received 510(k) approval from the US Food and Drug Administration (FDA) for its catheter-based ultrasound solution, Foresight intracardiac echocardiography (ICE) system.
The Foresight ICE system has been developed to visualize cardiac and great vessel anatomy, as well as other devices in the heart and great vessels of patients.
Claimed to be the first catheter-based ultrasound system, the Foresight ICE will offer both 2D and 3D ultrasound images of cardiac anatomy around the circumference of the catheter’s tip.
It features dual display Conavi Hummingbird imaging console and Foresight ICE catheter, which can be used to carry out minimally invasive cardiovascular procedures such as ablations and other procedures that need access to targeted regions of the heart.
Conavi Medical CEO Brian Courtney 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."
Formerly known as Colibri Technologies, Conavi Medical is involved in developing novel image guidance technologies to carry out minimally invasive procedures.
In 2014, Japan Lifeline entered into an agreement with Colibri to exclusively distribute its ICE imaging system in Japan.
Image: The Foresight ICE system will be used to visualize cardiac and great vessel anatomy and other devices in the heart and great vessels of patients. Photo: courtesy of dream designs / FreeDigitalPhotos.net.