FDA Clears Integrated Platform for Real-Time Cardiac Imaging and Catheter Guidance

Catheter-based treatment of cardiac arrhythmias relies on precise, real-time visualization and navigation for safe, accurate therapy delivery. Yet electrophysiology teams often use separate imaging, mapping, and guidance systems, increasing cognitive load and disrupting workflow. A newly cleared platform integrates these functions into a single system, streamlining decision-making while maintaining continuous anatomical context.

LUMA Vision (Dublin, Ireland) has received U.S. Food and Drug Administration (FDA) clearance expanding the capabilities of VERAFEYE, its procedural intelligence platform for minimally invasive cardiac procedures, announced on September 9, 2026. The update marks a step toward an integrated cardiac lab in which imaging, visualization, navigation, and guidance operate as a single system. With this clearance, VERAFEYE brings digital anatomy creation, catheter tracking, and guidance together within one environment.

VERAFEYE reconstructs three-dimensional models of the left and right atria with CT-like accuracy. Using a single 360-degree intracardiac imaging catheter, the platform captures raw ultrasound data to generate live two- and three-dimensional cardiac anatomy. It maintains continuous visibility of both imaging and ablation catheters through electromagnetic tracking and automated imaging, allowing clinicians to keep the ablation catheter in view without repeatedly repositioning the imaging catheter.

The platform lets physicians visualize and document ablation delivery directly on the anatomical model while the system analyzes procedural progress in real time. By presenting continuous context on the interplay among anatomy, devices, and therapy delivery, the system is intended to keep clinicians focused on treatment while preserving efficiency. The company positions this integration as the foundation for a more intelligent and connected approach to guiding cardiac procedures.

“What stands out about VERAFEYE is its ability to combine real-time imaging, visualization, and catheter tracking into a single integrated AI-driven platform. Rather than requiring physicians to piece together information from multiple sources, the system continuously provides anatomical and procedural context in real time without the need for repositioning of the imaging catheter. That represents an important step toward a more intelligent and connected approach to guiding cardiac procedures,” said Dr. Devi Nair, Chief of Cardiac Electrophysiology & Research at St. Bernards Healthcare and Arrhythmia Research.

Related Links
LUMA Vision