FDA Clears AI-Powered DeviceGuide for Minimally Invasive Mitral Valve Repair

The Food and Drug Administration (FDA) has issued 510(k) clearance for EchoNavigator R5.0 with DeviceGuide, an AI-enabled software that may streamline imaging guidance for minimally invasive repair of leaking mitral valves, a condition that reportedly affects over 35 million adults worldwide.

Philips, which developed the DeviceGuide with Edwards Lifesciences, said the AI software streamlines image guidance for mitral transcatheter edge-to-edge repair (M-TEER), a minimally invasive alternative to addressing mitral regurgitation.

Alleviating the burden of interpreting X-ray and ultrasound images on multiple screens during the M-TEER procedure, the DeviceGuide integrates these images into a single view and provides automated tracking and visualization of the Edwards PASCAL Ace mitral valve repair device, according to Philips.

“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,” explained Rebecca T. Hahn, M.D., the director of interventional echocardiography at Columbia University in New York, N.Y.

Atul Gupta, M.D., the chief medical officer of diagnosis and treatment at Philips, maintained that the AI-enabled DeviceGuide improves the safety of the M-TEER procedure.

“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,” noted Dr. Gupta. “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, helping them treat more patients safely and confidently.”

Philips noted that the DeviceGuide will be showcased at the American College of Cardiology 75^th Annual Scientific Session and Expo March 28-30 in New Orleans.