Philips has received 510(k) clearance from the FDA to market its EchoNavigator live image-guidance tool.
The technology helps interventional cardiologists and cardiac surgeons perform minimally invasive structural heart disease repairs by providing an integrated view of live x-ray and 3D images. During structural heart disease procedures, ultrasound provides imaging information on the heart’s soft tissue anatomy while x-ray imaging helps in visualizing catheters and heart implants.
EchoNavigator already received CE Mark in Europe. Amsterdam-based Philips reported the first systems have been installed in Europe and the U.S.