The US Food and Drug Administration has granted 510(k) clearance to EchoNavigator R5.0 with DeviceGuide, an artificial intelligence–enabled software solution designed to assist physicians during minimally invasive mitral valve repair procedures, according to a press release from Royal Philips.
The software provides real-time visualization and tracking of mitral transcatheter edge-to-edge repair devices during procedures used to treat mitral regurgitation, a condition affecting more than 35 million adults worldwide and over 2 million in the US. Minimally invasive transcatheter approaches offer an alternative to open-heart surgery in select patients, although these procedures remain technically complex and require precise coordination between operators interpreting multiple imaging modalities.
DeviceGuide integrates with the Philips Azurion image-guided therapy platform and builds on echo-fluoro fusion technology that combines live echocardiography and X-ray imaging into a single, unified view. The artificial intelligence algorithm automatically tracks the repair device and aligns imaging in real time, enabling physicians to assess device position and alignment during the procedure.
The software was developed in collaboration with Edwards Lifesciences and is currently intended for use with the Edwards PASCAL Ace Mitral Valve Repair System. According to the press release, DeviceGuide is designed to streamline procedural workflow by reducing manual adjustments of imaging views and by providing a shared visualization that supports communication across the interventional heart team.
Rebecca T. Hahn, MD, director of interventional echocardiography, of NewYork-Presbyterian/Columbia University Irving Medical Center, said that “Since [artificial intelligence] auto-aligns imaging to the device in real time and continuously informs the interventionalist about the location of the device in space on the imaging screen, it minimizes unnecessary repositioning of the imaging window, streamlines procedural guidance and may improve the precision of device implantation.” Susheel Kumar Kodali, MD, interventional cardiologist, of the same institution, noted that “Having a single, intuitive presentation of real-time target, orientation and auto device-aligned views simplifies this procedure and improves team communication.”
Philips highlighted that the software functions as an assistive tool, with physicians maintaining procedural control. The company stated that the technology is part of a broader effort to integrate imaging, devices, and real-time data within a connected cardiology ecosystem aimed at improving procedural efficiency and team coordination.
Commercial availability in the US remains subject to market release and applicable regulatory requirements, and availability outside the US varies by region.
Source: Royal Philips
