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

DUBLIN, Sept. 9, 2026 /PRNewswire/ -- LUMA Vision, a medtech company transforming minimally invasive cardiac procedures, today announced FDA clearance expanding the capabilities of VERAFEYE, its procedural intelligence platform. The news marks another significant step toward the company's vision for the cardiac lab of the future, where imaging, visualization, navigation, and guidance operate as a single integrated system, giving physicians continuous real-time visibility into the interplay of anatomy, devices, and therapy delivery.

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."

Delivering Procedural Intelligence: How VERAFEYE is the Foundation of the Cardiac Lab of the Future

• Imaging: VERAFEYE uses a single 360° imaging catheter to capture raw ultrasound data and construct real-time 2D and 3D anatomy of the heart.
• Visualization: VERAFEYE builds a live anatomical map of the heart, valves, great vessels, and surrounding structures, giving physicians a complete real-time view of the patient's anatomy.
• Navigation: VERAFEYE maintains continuous tracking of both the imaging and ablation catheters, so physicians never have to stop and manually reposition to keep the ablation catheter in view, allowing them to stay focused on treating the patient.
• Guidance: VERAFEYE lets physicians mark locations directly on the anatomical model as ablation therapy is delivered, confirming alignment and increasing confidence without compromising efficiency. As VERAFEYE builds a database of real anatomy across thousands of cases, expanded guidance will be available in the future to physicians, with the goal of helping them decide, not just see.

"This clearance is another step toward the cardiac lab of the future and our commercial launch of VERAFEYE in early 2027," said Fionn Lahart, CEO and co-founder of LUMA Vision. "By bringing imaging, visualization, navigation and guidance together into a single platform, VERAFEYE delivers significant clinical impact with virtually no workflow disruption. It's a new paradigm for guiding arrhythmia procedures, and just the beginning of our procedural intelligence platform, which will be expanded into LAA and structural heart."

To learn more about VERAFEYE, visit www.lumavision.com.

About LUMA Vision

LUMA Vision is a privately held, medical device company based in Dublin, Ireland. LUMA Vision designs and develops cutting edge innovative technologies to significantly advance healthcare and solve truly global unmet clinical needs. VERAFEYE™ is a novel ultrasound based cardiac visualization and navigation platform for generating a 360-degree view, navigating and imaging all structures and devices around the catheter with an unprecedented field of view. With a commitment to advancing patient care, LUMA Vision focuses on delivering groundbreaking products that enhance clinical outcomes and improve lives around the world. LUMA Vision was founded by CEO Fionn Lahart and CTO Christoph Hennersperger. Learn more about LUMA Vision and VERAFEYE™ at www.lumavision.com

SOURCE LUMA Vision