FDA clears Philips AI tool for real-time guidance in minimally invasive heart valve repair

Royal Philips received FDA clearance for DeviceGuide, an AI-powered software that aids physicians during minimally invasive mitral valve repair procedures. DeviceGuide integrates live ultrasound and X-ray images to provide real-time visualization and navigation of the repair device, improving precision and coordination in complex heart interventions. Developed with Edwards Lifesciences, this technology aims to make mitral valve repairs safer and more efficient, potentially benefiting millions with mitral regurgitation. The solution will be showcased at the 2026 American College of Cardiology meeting and is part of Philips' broader connected cardiology ecosystem to enhance patient care from diagnosis to recovery.