FDA clears new AI software for mitral valve repair
Philips has secured U.S. Food and Drug Administration (FDA) clearance for EchoNavigator R5.0 with DeviceGuide, the company’s artificial intelligence (AI)-enabled software for mitral transcatheter edge-to-edge repair (M-TEER).
Philips collaborated with Edwards Lifesciences on the new software, which was built with real-time AI guidance in mind.
The new software tracks and visualizes the mitral valve repair device during M-TEER, using ultrasound and X-ray imaging to produce a single, integrated view for the care team. Philips collaborated with Edwards Lifesciences on its development, and EchoNavigator R5.0 with DeviceGuide was built with Edwards’ PASCAL Ace M-TEER technology in mind.
“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,” Atul Gupta, MD, a veteran radiologist and chief medical officer of diagnosis and treatment at Philips, said in a statement. “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, helping them treat more patients safely and confidently.”
“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,” added Rebecca T. Hahn, MD, director of interventional echocardiography at NewYork-Presbyterian/Columbia University Irving Medical Center, who provided feedback as Philips and Edwards developed this new software. “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.”
In December, Hahn et al. published early data on the EchoNavigator R5.0 with DeviceGuide in JACC: Case Reports.[1] According to the group, this advanced AI technology “has the potential for improving the safety, efficiency, and efficacy of M-TEER implantation for both routine and anatomically complex cases irrespective of operator experience.”
Click here to read the full analysis in JACC: Case Reports, an American College of Cardiology journal.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.