Royal Philips Electronics, parent company of Philips Healthcare, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its EchoNavigator live image-guidance tool.
EchoNavigator helps interventional cardiologists and cardiac surgeons perform minimally invasive structural heart disease repairs by providing an integrated view of live x-ray and 3D ultrasound images, according to the firm.
EchoNavigator previously received the European CE Mark, and the first systems have already been installed in Europe and the U.S., Philips said.
