by
Gus Iversen, Editor in Chief | March 31, 2026
Royal Philips has received FDA 510(k) clearance for EchoNavigator 5.0 with DeviceGuide, a software tool designed to assist clinicians during minimally invasive mitral valve repair procedures.
The Amsterdam-based company said the system uses artificial intelligence to track and display the position of repair devices in real time, supporting transcatheter edge-to-edge repair (M-TEER) procedures. DeviceGuide integrates with Philips’ Azurion image-guided therapy platform and combines live echocardiography and X-ray imaging into a single view.
Mitral regurgitation affects an estimated 35 million people globally, with more than 2 million cases in the United States. Transcatheter approaches such as M-TEER offer an alternative to open-heart surgery for selected patients but require coordination between imaging specialists and interventional cardiologists, as well as continuous interpretation of multiple imaging streams.
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DeviceGuide builds on Philips’ echo-fluoro fusion technology and is designed to automatically track the Edwards PASCAL Ace repair device during procedures. The system overlays device orientation and trajectory on fused imaging, with the goal of improving navigation and reducing the need for repeated imaging adjustments.
“The AI software serves as an assistive tool; the physician always remains in control,” said Dr. Atul Gupta, chief medical officer, diagnosis & treatment, at Philips. “This isn’t about replacing expertise, it’s about amplifying it.”
Philips developed the software in collaboration with Irvine, California-based Edwards Lifesciences. Clinical input included teams at NewYork-Presbyterian/Columbia University Irving Medical Center.
“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,” said Dr. Rebecca T. Hahn, director of interventional echocardiography.
Dr. Susheel Kumar Kodali, director of the Structural Heart and Valve Center, added that a unified visualization of device position and anatomy can simplify communication during procedures.
The software is cleared for use in the U.S. and is intended for use with the Edwards PASCAL Ace system. Availability in other markets will depend on regulatory approvals.
