LUMA Vision Wins FDA Clearance for VERAFEYE Ahead of 2027 Launch
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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.