Philips has obtained US Food and Drug Administration (FDA) clearance for DeviceGuide, an artificial intelligence (AI)-based software designed to provide physicians with real-time visual assistance during mitral valve repair procedures.
DeviceGuide has been built on Philips’ EchoNavigator echo-fluoro fusion technology, which combines live echocardiography images from Philips EPIQ CVxi cardiovascular platform with live X-ray images from the Dutch company’s Azurion image-guided therapy system.
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Developed in collaboration with Edwards Lifesciences, DeviceGuide is designed to streamline mitral transcatheter edge-to-edge repair (M-TEER) workflows during mitral regurgitation (MR) treatment procedures.
MR is a heart condition wherein the mitral valve does not close properly, causing blood to flow backward into the left atrium instead of moving forward to the body. It results in shortness of breath and fatigue, and in severe cases, heart failure. The condition is thought to affect more than 35 million adults worldwide, with an estimated two million patients in the US. In select patient populations, minimally invasive transcatheter techniques such as M-TEER offer an alternative to open-heart surgery.
Currently intended for use with Edwards PASCAL Ace mitral valve repair device, DeviceGuide combines live ultrasound and x-ray images of the PASCAL into a single, consolidated view. Philips did not disclose an anticipated market release date for DeviceGuide, stating only that commercial availability of the software is subject to market release and applicable regulatory requirements.
Philips’ chief medical officer, Dr Atul Gupta, commented: “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, helping them treat more patients safely and confidently.”
Viewed as one of the most complex structural heart procedures, M-TEER involves making a small skin incision to access a vein to allow for the introduction of a catheter to the heart to deliver a repair device to the diseased mitral valve. According to Philips, given that the mitral valve is an inherently complex structure, transcatheter valve repair requires experienced physicians to position the device delivery system.
Mark Stoffels, business leader for image-guided therapy systems at Philips, explained: “By assisting physicians with real-time visualisation and navigation inside the beating heart, DeviceGuide helps them manage that complexity, and perform procedures more confidently, with the ultimate goal to treat more patients effectively.”
In 2025, Edwards transcatheter mitral and tricuspid therapies (TMTT) portfolio achieved revenue of $550.6m, representing growth of 56.4% year-over-year (YoY) versus $352.1m in 2024. Philips, meanwhile, does not disclose TMTT-related sales.
GlobalData analysis reveals that the global transcatheter heart valve market is growing at a CAGR of 11.3% and is projected to reach a valuation of almost $27bn in 2035, up from around $9.3bn in 2025.
