LUMA Vision Wins FDA Nod for VERAFEYE Expansion

LUMA Vision has obtained U.S. Food and Drug Administration (FDA) clearance to expand the capabilities of its VERAFEYE procedural intelligence platform for minimally invasive cardiac procedures.

The clearance brings 3D anatomy, catheter tracking, and procedural guidance onto one platform, providing real-time anatomical visualization and guidance. VERAFEYE was initially FDA cleared in early 2025.

It reconstructs 3D models of the left and right atria with CT-like accuracy, enables physicians to visualize and document ablation delivery, and continuously tracks imaging and ablation catheters through electromagnetic tracking and automated imaging.

The news advances the company’s vision for a future cardiac lab where imaging, visualization, navigation, and guidance function as one integrated system, providing physicians real-time visibility into anatomy, devices, and therapy delivery.

More about VERAFEYE

VERAFEYE uses a 360° imaging catheter to capture ultrasound data and generate real-time 2D and 3D cardiac anatomy. The platform creates a live map of the heart, valves, great vessels, and surrounding structures while continuously tracking imaging and ablation catheters, removing the need for manual repositioning.

Physicians can also mark treatment sites directly on the anatomical model to confirm ablation alignment. As the system builds a database of real-world anatomy across thousands of procedures, future guidance capabilities aim to help physicians make procedural decisions, LUMA said, not simply visualize anatomy.

“This clearance is another step toward the cardiac lab of the future and our commercial launch of VERAFEYE in early 2027,” said CEO Fionn Lahart. “By bringing imaging, visualization, navigation and guidance together into a single platform, VERAFEYE delivers significant clinical impact with virtually no workflow disruption. It’s a new paradigm for guiding arrhythmia procedures, and just the beginning of our procedural intelligence platform, which will be expanded into LAA and structural heart.”