Philips has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for EchoNavigator R5.0 with DeviceGuide, an AI-powered tool that assists physicians during mitral transcatheter edge-to-edge repair (M-TEER) procedures.
Developed in collaboration with Edwards Lifesciences, DeviceGuide automatically tracks and visualizes the Edwards Pascal Ace mitral valve repair device by combining live echocardiography images from Philips’ EPIQ CVxi platform with live x-ray images from its Azurion image-guided therapy system into a single integrated view. The software is built on Philips’ existing EchoNavigator echo-fluoro fusion technology.
M-TEER procedures require two operators to simultaneously interpret x-ray and ultrasound images on multiple screens while making adjustments to position a repair device on a moving valve, the firm said.
DeviceGuide is currently intended for use with the Edwards Pascal Ace system. Commercial availability is subject to market release, and availability outside the U.S. varies by country and regulatory status.
Early clinical experience using the software was described in a first-in-human publication in JACC: Case Reports, the company said.
Philips will showcase DeviceGuide at the American College of Cardiology 2026 meeting in New Orleans.