LUMA Vision Expands Clinical Use of VERAFEYE™ in Guiding AF Ablations and Completes Key 510k Submission.

DUBLIN, March 19, 2026 /PRNewswire/ -- LUMA Vision, a leader in cardiac 4D imaging and navigation, today announces the expansion of its clinical program with the first patient enrolments in two additional European studies at Na Homolce Hospital in Prague with Dr. Vivek Reddy and Dr. Petr Neuzil, as well as at KBC University Hospital in Split with Dr. Ante Anic and Dr. Anish Amin. The studies evaluate the VERAFEYE™ 4D navigation and imaging platform for guiding catheter ablation procedures using a range of ablation technologies.

The successful start of these two studies demonstrates the versatility of the VERAFEYE™ platform guiding ablation workflows entirely through live intra-procedural imaging (2D and 4D), and precise digital anatomical models, enabling intuitive and streamlined ablation guidance and navigation. Patients were treated with multiple Pulsed Field Ablation (PFA) systems, demonstrating the compatibility of the VERAFEYE™ system. Using its unparalleled 360-degree imaging coverage, advanced catheter guidance and ablation workflow support, VERAFEYE™ enables efficient single-operator procedures with unmatched precision.

The system utilised in these procedures is the latest iteration of VERAFEYE™, for which LUMA Vision recently submitted a 510(k) application, initiating the regulatory approval process. This version will form the basis of the commercial launch in 2026 with VERAFEYE™ for enhanced indications as an anatomical imaging and guidance system for cardiac electrophysiology procedures.

Both milestones were highlighted during a joint visit to LUMA Vision's Munich facility by Judith Gerlach, Bavaria's Minister for Health, and Jennifer Carroll MacNeill, Ireland's Minister for Health, as part of an event focused on strengthening European collaboration in cardiac healthcare innovation. The visit emphasised the role of Ireland and Germany as leading hubs for DeepTech and MedTech innovation with global impact.

"What you are building here with the VERAFEYE™ platform is genuinely a world first technology. An open platform, AI–driven 4D imaging system designed to help cardiologists see the heart in a way that has never been possible," said Jennifer Carroll MacNeill, Ireland's Minister for Health. Judith Gerlach, Bavaria's Minister for Health, Care and Prevention commented, "LUMA Vision is a powerful example of European innovation in action - Irish and Bavarian teams working together to develop breakthrough medical technologies."

Jenny Melia, CEO of Enterprise Ireland said: "Enterprise Ireland is committed to supporting Irish companies to start, grow and scale. We have supported LUMA Vision from its earliest stages, and today's milestones with the VERAFEYE™ platform demonstrate exactly why this is a breakthrough platform: co–developed across Irish and Bavarian teams, backed by shared European investment, and now delivering real clinical impact."

With regulatory clearance and commercial launch later this year, the company is preparing to scale up in key markets globally. The open imaging and guidance platform enables physicians to perform cardiac ablation using their preferred ablation tool while improving procedural speed, efficiency, and precision. Beyond ablation, the technology is expected to expand into structural heart interventions, including left atrial appendage closure and valve placements.

About LUMA Vision

LUMA Vision is a privately held medical technology company operating in Dublin, Ireland, and Munich, Germany. The company designs and develops next-generation cardiac visualisation and navigation systems that empower clinicians to see and treat with unmatched precision. VERAFEYE™, LUMA Vision's flagship platform, delivers a real-time, 360° intracardiac view with an unprecedented field of visualisation, redefining procedural accuracy in electrophysiology and structural heart interventions. Founded by CEO Fionn Lahart and CTO Christoph Hennersperger, LUMA Vision is committed to transforming cardiac care through innovation that improves outcomes and saves lives.

Learn more at www.lumavision.com

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