AI-Guided 4D Imaging Revolutionizes Cardiac Ablation Procedures

DUBLIN, IRELAND – January 07, 2026 – A new frontier in treating complex heart rhythm disorders is emerging, as Irish medical technology firm LUMA Vision announced the successful completion of 15 persistent atrial fibrillation (AF) ablation procedures guided by its groundbreaking VERAFEYE™ 4D imaging and navigation system. The clinical study, conducted in partnership with CardioFocus, Inc., showcases a significant leap forward in simplifying image-guided cardiac care, potentially setting a new standard for precision and efficiency in the operating room.

The announcement signals a pivotal moment for electrophysiology, the field dedicated to the heart's electrical system. By combining artificial intelligence with real-time, four-dimensional visualization, the technology aims to give doctors an unprecedented view inside the beating heart, transforming how they perform delicate ablation procedures for atrial fibrillation, the world's most common arrhythmia.

A New Dimension in Cardiac Visualization

At the core of this advancement is the VERAFEYE™ platform, a system that moves far beyond the limitations of traditional 2D intracardiac echo (ICE) and even existing 3D mapping systems. VERAFEYE™ utilizes a proprietary 4D ultrasound-based catheter to provide a live, 360-degree, volumetric view of the heart's chambers. This allows clinicians to see anatomical structures with enhanced depth and clarity from up to 120mm away, all without the need for tissue contact.

A key innovation is the system's "Rapid Digital Anatomy" (RDA) feature, which leverages advanced AI and deep learning algorithms. From a single position in the right atrium, the system can generate a CT-quality, 3D anatomical model of both atria in under 60 seconds. This digital reconstruction, combined with automatic tracking of other therapeutic catheters, provides a dynamic and interactive roadmap for the entire procedure.

This technological leap enables what has been described as a highly streamlined "two-catheter workflow." In the recent clinical procedures, clinicians used the VERAFEYE™ system for all imaging and navigation needs, while a second catheter—the CardioFocus QuickShot™ Nav—was used to deliver the therapeutic energy.

"Using an empirical lesion set is the preferred approach for de novo AF ablation in the persistent population. The VERAFEYE system's disruptive approach to 3D geometry creation allowed me to only use one catheter for imaging (2D ICE), navigation and Rapid Digital Anatomy (RDA), which is unique in the market," said Dr. Ante Anic, Director of Electrophysiology at KBC Split, Croatia, where the procedures were performed. He noted that when this is paired with a pulsed field ablation (PFA) platform, "operators have a perfect 2 catheter tool set to deliver their preferred empirical lesion set, including linear ablation for beyond PVI, in less than an hour. This is the new definition of procedural efficiency."

This integrated approach also eliminates the need for external fluoroscopy (X-ray) or pre-procedural CT scans, reducing radiation exposure for both the patient and the medical team.

Redefining Treatment for Persistent Atrial Fibrillation

The successful application of VERAFEYE™ in patients with persistent atrial fibrillation is particularly significant. While paroxysmal (intermittent) AF is often treated by electrically isolating the pulmonary veins (PVI), persistent AF—where the arrhythmia is continuous—typically requires more extensive ablation, including lines on the posterior wall of the left atrium. These complex procedures demand exceptional anatomical accuracy to be successful and to avoid damaging adjacent structures like the esophagus.

VERAFEYE™'s ability to provide a real-time, 4D view of the beating heart, coupled with its precise anatomical models, directly addresses this challenge. The system is designed to give physicians the confidence to create complete and durable lesion sets with greater accuracy, which is critical for improving long-term patient outcomes and reducing the need for repeat procedures.

The technology is arriving at a transformative time, coinciding with the rise of Pulsed Field Ablation (PFA). PFA is a novel, non-thermal energy source that selectively targets heart muscle cells while sparing surrounding tissues. The synergy between VERAFEYE's precision guidance and PFA's tissue-selective energy delivery is a powerful combination.

"This offers a level of detail and real-time spatial context unmatched by traditional imaging methods," commented one leading electrophysiologist familiar with the technology, who was not involved in the study. "For complex procedures like posterior wall isolation, seeing the full, dynamic anatomy as you work is a game-changer. It has the potential to make these interventions not only faster but fundamentally safer."

"Our goal is to bring accuracy, efficiency, and precision to cardiac procedures to help achieve positive patient outcomes," stated Fionn Lahart, CEO of LUMA Vision. "Driven by advanced machine learning and AI, VERAFEYE is a category-defining, powerful cardiac guidance platform that aims to provide a new standard of care in combination with integrated third-party devices and catheters."

A Strategic Play in a Competitive Market

LUMA Vision's progress positions the Dublin-based company as a key innovator in the multi-billion-dollar cardiac rhythm management market. The company is not developing its own ablation energy source but is instead creating a vital enabling technology that can enhance procedures regardless of the therapeutic catheter used. This "Switzerland" strategy is particularly astute in the rapidly evolving PFA space, which is currently dominated by industry giants like Medtronic, Boston Scientific, and Johnson & Johnson.

By partnering with companies like CardioFocus, LUMA Vision demonstrates its platform's value in optimizing the workflow of next-generation ablation systems. The company secured a critical milestone in April 2025 with U.S. Food and Drug Administration (FDA) 510(k) clearance for the VERAFEYE™ platform, paving the way for commercialization. That clearance, supported by a $22 million funding round, has set the stage for a planned global market launch in 2026.

The company's ambitions extend beyond AFib. According to Lahart, the platform's ability to provide unparalleled clarity will eventually enable other complex interventions, such as left atrial appendage closure and structural heart procedures. This broad applicability suggests a long-term strategy to become an indispensable tool across a wide spectrum of interventional cardiology. As the technology moves from clinical studies toward broader market availability, its impact on procedural standards and patient care will be closely watched by the entire cardiovascular community.