LUMA Vision Secures FDA Clearance for VERAFEYE Platform, Advancing Cardiac Procedural Intelligence
LUMA Vision, a medical technology company, has announced that it received FDA clearance for its VERAFEYE procedural intelligence platform. This clearance expands the platform's capabilities, moving the company closer to its goal of creating an integrated cardiac lab of the future. VERAFEYE aims to unify imaging, visualization, navigation, and guidance into a single system, providing physicians with continuous real-time visibility into the interplay of cardiac anatomy, medical devices, and therapy delivery during minimally invasive cardiac procedures. The system reconstructs 3D models of the heart's left and right atria with CT-like accuracy, allows for direct visualization and documentation of ablation delivery on the anatomy, and maintains continuous tracking of both imaging and ablation catheters through electromagnetic tracking and automated imaging. Dr. Devi Nair, Chief of Cardiac Electrophysiology & Research at St. Bernards Healthcare, highlighted the system's ability to combine real-time imaging, vis...