Dublin – – September 13, 2026 -- LUMA Vision has secured an expanded FDA clearance for VERAFEYE, its procedural intelligence platform for minimally invasive cardiac procedures, moving the company closer to a planned commercial launch in early 2027.
VERAFEYE now unifies digital anatomy creation, catheter tracking, and guidance on a single platform
The new clearance allows VERAFEYE to reconstruct 3D models of the left and right atria with CT-like accuracy using a single 360° imaging catheter that captures raw ultrasound data. The platform lets physicians visualize and document ablation delivery directly on the anatomy while maintaining continuous tracking of both imaging and ablation catheters through electromagnetic tracking and automated imaging.
The system eliminates repeated catheter repositioning during procedures
Dr Devi Nair, Chief of Cardiac Electrophysiology & Research at St. Bernards Healthcare and Arrhythmia Research, said the platform provides continuous anatomical and procedural context without requiring physicians to reposition the imaging catheter or piece together data from multiple sources.
LUMA Vision targets a 2027 commercial rollout with plans to expand beyond arrhythmia
CEO and co-founder Fionn Lahart said the clearance marks another step toward commercial launch in early 2027, describing VERAFEYE as delivering clinical impact with minimal workflow disruption. The company plans to extend the procedural intelligence platform into left atrial appendage (LAA) and structural heart applications following the arrhythmia-focused launch.
The platform is designed to build a growing anatomical database across cases
As VERAFEYE accumulates data from thousands of procedures, LUMA Vision intends to expand guidance capabilities to help physicians make treatment decisions, not just visualize anatomy.