FDA Clears Philips' EchoNavigator R5.0 with DeviceGuide for Real-Time AI Guidance in Minimally Invasive Mitral Valve Repair

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Royal Philips received U.S. FDA 510(k) clearance on March 26, 2026, for EchoNavigator R5.0 with DeviceGuide, an AI-powered software for real-time tracking and visualization during minimally invasive mitral transcatheter edge-to-edge repair (M-TEER) procedures123

DeviceGuide integrates live ultrasound and X-ray images to track Edwards Lifesciences' PASCAL Ace mitral valve repair device, enhancing physician navigation and confidence12

Developed in collaboration with Edwards Lifesciences and integrates with Philips Azurion image-guided therapy platform1

Will be showcased at the American College of Cardiology (ACC) 2026 meeting in New Orleans12

Currently intended for use with Edwards PASCAL Ace system; U.S. availability subject to market release, varies internationally1

Sources:

1. https://www.globenewswire.com/news-release/2026/03/26/3263118/0/en/FDA-clears-Philips-AI-solution-that-provides-real-time-guidance-during-complex-minimally-invasive-heart-valve-repair.html

2. https://www.fiercebiotech.com/medtech/philips-ai-cath-lab-copilot-nets-fda-clearance

3. https://conexiant.com/cardiology/articles/fda-clears-ai-guidance-tool-for-mitral-repair/