Royal Philips, a global leader in health technology, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an AI-powered software solution that assists physicians during one of interventional cardiology’s most technically demanding procedures – repairing leaking mitral valves through a minimally invasive approach.
DeviceGuide was developed in close collaboration with Edwards Lifesciences, the global leader in structural heart innovation, aligning Philips’ imaging and AI expertise with Edwards’ expertise in valvular heart therapy development. Together, the companies have innovated image guidance of the mitral transcatheter edge-to-edge repair (M-TEER) workflow to make these complex, minimally invasive heart valve repair procedures more intuitive and streamlined.
DeviceGuide will be showcased at the American College of Cardiology (ACC) 2026 meeting in New Orleans, one of the world’s leading forums for cardiovascular innovation.
A leaking mitral valve, known as mitral regurgitation (MR), affects more than 35 million adults worldwide and over 2 million in the U.S. Minimally invasive transcatheter techniques such as M-TEER offer an alternative to open heart surgery in selective patient populations.
During M-TEER procedures, physicians make a small skin incision to access a vein, which allows the introduction of a catheter to the heart to deliver a repair device to the diseased mitral valve. Because the mitral valve is inherently a complex and heterogeneous structure, transcatheter repair of the valve requires experienced physicians to position the device delivery system and guide the placement of the device. In guiding and positioning the repair device, the intraprocedural heart team must interpret both X-ray and ultrasound images on multiple screens, communicate and coordinate movements between two operators, and make precise adjustments to grasp the moving valve leaflets and then confirm the result in real time. The process demands accuracy, coordination, and experience from the entire team – and this is where DeviceGuide can help with navigation guidance.
Built on Philips’ EchoNavigator echo-fluoro fusion technology, which combines live echocardiography images from Philips EPIQ CVxi cardiovascular platform with live X-ray images from Philips Azurion image-guided therapy system, DeviceGuide brings real-time AI guidance directly into the procedure room.
The software’s AI algorithm automatically tracks and visualises the Edwards PASCAL Ace mitral valve repair device, combining live ultrasound and X-ray images into a single, integrated view. This helps clinicians navigate and position the device with greater clarity and confidence.
“The AI software serves as an assistive tool; the physician always remains in control. This isn’t about replacing expertise – it’s about amplifying it,” explains Dr. Atul Gupta, Chief Medical Officer, Diagnosis & Treatment at Philips. “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, helping them treat more patients safely and confidently.”
