FDA OKs Philips’ DeviceGuide for Heart Valve Repair Guidance

Philips has received U.S. Food and Drug Administration (FDA) 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an artificial intelligence (AI)-powered software tool that helps physicians repair leaky mitral valves through a minimally invasive approach.

DeviceGuide was developed in partnership with Edwards Lifesciences, marrying Philips’ imaging and AI expertise with Edwards’ expertise in valvular heart therapy development. Together, the duo innovated image guidance of the mitral transcatheter edge-to-edge repair (M-TEER) workflow to make the procedure more intuitive and streamlined.

DeviceGuide brings real-time AI guidance into the procedure room. It’s built on Philips’ EchoNavigator echo-fluoro fusion tech, which combines live echocardiography images from the CVxi cardiovascular platform with live X-ray images from the Azurion image-guided therapy system.

The software’s AI algorithm tracks and visualizes the Edwards Pascal Ace mitral valve repair device, combining live ultrasound and X-ray images into one integrated view.

“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,” explained 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.”

In developing DeviceGuide, Philips and Edwards worked closely with investigational sites in Europe and the U.S., including a team at the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Irving Medical Center, led by interventional cardiologist Susheel Kumar Kodali, MD, director, and Rebecca T. Hahn, MD, director of interventional echocardiography.

“In helping to guide mitral repair procedures, one of my roles as an echocardiographer is to help the interventional cardiologist understand the complex anatomy of the valve which will determine the orientation, trajectory and position of the repair device relative to the target and the surrounding structures,” said Dr. Hahn. “Since AI 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.”

DeviceGuide extends Philips’ connected cardiology portfolio that helps physicians care for heart patients from diagnosis through recovery. It also represents a step toward Philips’ vision of the AI-powered cath lab of the future where imaging, devices, and real-time data are intelligently connected to reduce procedural complexity and improve consistency.