FDA cleared LUMA Vision's VERAFEYE platform as an anatomical imaging and guidance system for cardiac electrophysiology procedures, the Dublin company said on September 9. The clearance covers reconstruction of 3D atrial models, continuous electromagnetic tracking of both the imaging catheter and the ablation catheter, and marking ablation sites directly on the anatomy. LUMA Vision completed the 510(k) submission in March 2026.
The first VERAFEYE clearance, in April 2025, covered 2D and 4D visualization from a 360 degree imaging catheter. This one moves the product from an imaging system toward a navigation system, which is the box electrophysiologists currently buy from Abbott, Johnson & Johnson and Boston Scientific. Commercial launch is set for early 2027.
The company ran European ablation studies at Na Homolce Hospital in Prague and KBC University Hospital in Split, pairing VERAFEYE with more than one pulsed field ablation system. Staying energy agnostic is the sensible play for a small imaging vendor, because the mapping incumbents all sell their own ablation catheters. LUMA Vision was founded in 2017 and operates from Dublin and Munich.