LUMA Vision Secures FDA Clearance Advancing Procedural Intelligence as the Foundation of the Cardiac Lab of the Future

Latest Clearance Expands VERAFEYE's Capabilities as the Company Prepares for Commercial Launch in Early 2027

With this clearance, VERAFEYE unifies digital anatomy creation, catheter tracking, and guidance on a single platform, revealing true anatomy in real time, analyzing it as the procedure unfolds, and guiding the physician to every target along the way. The system reconstructs 3D models of the left and right atria with CT-like accuracy, allows physicians to visualize and document ablation delivery directly on the anatomy, and maintains continuous visibility of both imaging and ablation catheters through electromagnetic tracking and automated imaging.

“What stands out about VERAFEYE is its ability to combine real-time imaging, visualization, and catheter tracking into a single integrated AI-driven platform,” said Dr Devi Nair, Chief of Cardiac Electrophysiology & Research at St. Bernards Healthcare and Arrhythmia Research. “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.”

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