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Home » FDA clears Philips AI tech for guidance in heart valve repair

FDA clears Philips AI tech for guidance in heart valve repair

March 26, 2026 By Sean Whooley

Philips DeviceGuide used with EchoNavigator (1)
The DeviceGuide in use with EchoNavigator. [Image courtesy of Philips]
Philips (NYSE:PHG) announced today that it received FDA 510(k) clearance for its EchoNavigator R5.0 with DeviceGuide.

Amsterdam-based Philips designed this AI-powered software solution to assist physicians during minimally invasive mitral valve repairs. The company developed its DeviceGuide solution in collaboration with Edwards, combining medical imaging expertise with leadership in structural heart devices. The companies say that, together, they reimagined key parts of the mitral TEER (M-TEER) procedural workflow. Philips unveiled DeviceGuide in November 2025.

Current leading TEER solutions in the space include Edwards’ Pascal and Abbott’s TriClip and MitraClip.

M-TEER procedures require a small skin incision to access a vein. This allows the introduction of a catheter to the heart to deliver a repair device to the diseased mitral valve.

When performing this procedure, physicians must position and guide device placement, interpreting both X-ray and ultrasound images on multiple screens, Philips said. They must communicate and coordinate movements between two operators, and make precise adjustments to grasp the moving valve leaflets and then confirm the result in real time.

According to Philips, the process demands accuracy, coordination and experience, with which DeviceGuide can assist.

“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,” said Dr. Atul Gupta, chief medical officer, Diagnosis & Treatment at Philips. “By embedding AI into the procedure, DeviceGuide gives physicians an extra pair of eyes, helping them treat more patients safely and confidently.”

More about the valve repair guidance tech from Philips

Philips built the technology on its EchoNavigator echo-fluoro fusion technology. This platform combines live echocardiography images from the Philips EPIQ CVxi cardiovascular platform with live X-ray images from the Philips Azurion image-guided therapy system. DeviceGuide then brings real-time AI guidance directly into the procedure room.

The software’s AI algorithm automatically tracks and visualizes the Edwards Pascal valve through combined ultrasound and X-ray.  Clinicians can use the single, integrated view to navigate and position the device with greater clarity and confidence.

According to Dr. Rebecca T. Hahn, director of interventional cardiology at the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia University Irving Medical Center, said AI auto-aligns imaging to the device in real-time. It minimizes unnecessary repositioning of the imaging window, streamlines guidance and improves precision, she said.

Dr. Susheel Kumar Kodali, an interventional cardiologist at that site, said DeviceGuide provides a visual overlay, trajectory line and orientation line of the therapy device in both live 3D echo and fluoroscopic images during procedures.

“Structural heart procedures are among the fastest-growing areas in cardiology, and also among the most complex. By assisting physicians with real-time visualization 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,” said Mark Stoffels, business leader, Image Guided Therapy Systems at Philips. “It fits seamlessly into cath-lab workflows and gives the entire team a shared view of the procedure, improving coordination and confidence.”

Filed Under: 510(k), Artificial Intelligence (AI), Cardiac Implants, Cardiovascular, Digital Health, Food & Drug Administration (FDA), Health Technology, Imaging, Machine Learning (ML), Regulatory/Compliance, Replacement Heart Valves, Software / IT, Structural Heart, Structural Heart, Ultrasound Tagged With: Philips, Royal Philips

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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