LUMA Vision, a Dublin-headquartered medical device company, has secured U.S. Food and Drug Administration (FDA) clearance for its innovative Verafeye catheter-based imaging system, marking a significant advancement in cardiac visualization technology.
The Verafeye platform combines four-dimensional (4D) ultrasound-based imaging with magnetic navigation capabilities to provide clinicians with real-time, 360-degree visualization of cardiac anatomy during complex procedures. This technology represents a substantial improvement over traditional two-dimensional (2D) imaging catheters that limit clinicians' ability to view cardiac structures from all angles.
Revolutionary Imaging Capabilities
Verafeye's proprietary catheter sensor integrates advanced digital imaging and deep learning algorithms to generate volumetric, real-time cardiac images. The system can capture detailed 4D images from up to 120mm away from the catheter, providing unprecedented visualization depth and clarity during interventions.
"Our clinical experience with Verafeye is exciting, with the potential to simplify procedural workflow and efficiency," said Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the Verafeye system. "Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity."
The technology eliminates the need for external imaging systems such as X-ray or CT scanners during procedures, potentially reducing radiation exposure for both patients and healthcare providers.
Clinical Applications and Benefits
The Verafeye system is designed to enhance precision and confidence during complex electrophysiology and structural heart procedures, including cardiac arrhythmia treatments and left atrial appendage closures. By providing comprehensive visualization, the platform enables clinicians to make more informed decisions, potentially reducing procedure time and minimizing risks.
Dr. Anish Amin, System Medical Chief for Cardiac Electrophysiology at OhioHealth Heart and Vascular, described Verafeye's capabilities as demonstrating "a necessary path forward in precision imaging and a strong foundation to further advance the standard of care."
The system is also prepared for magnetic tracking and navigation of third-party catheters, which will further empower clinicians to perform complex procedures with greater precision and control in the future.
Market Context and Financing
LUMA Vision completed a $22 million Series A3 financing round in 2023 to support FDA clearance and commercialization activities for Verafeye. Investors included EQT Lifesciences, ABV Uni Fund, imec.xpand, Atlantic Bridge Growth Fund, and Bayern Kapital.
The cardiac electrophysiology market represents a significant opportunity for innovative technologies like Verafeye. According to GlobalData analysis, the market for Pulsed Field Ablation, a technique used in cardiac electrophysiology, exceeded $500 million in 2024, with Medtronic and Boston Scientific as the main players with their respective PulseSelect and FARAPULSE PFA systems.
Company Leadership Perspective
Fionn Lahart, CEO of LUMA Vision, expressed pride in the FDA clearance achievement: "We are incredibly proud of this achievement and the potential impact Verafeye will have in areas such as cardiac arrhythmias, left atrial appendage closure and structural heart. Our team and partners have worked tirelessly alongside clinicians to develop a product that can be the future of cardiac navigation."
LUMA Vision, founded by CEO Fionn Lahart and CTO Christoph Hennersperger, is based in Dublin, Ireland, and Munich, Germany. The company focuses on developing cutting-edge technologies to address unmet clinical needs in healthcare.
Future Implications
The successful approval of the Verafeye system represents a significant step toward improving procedural workflows in cardiac interventions. By providing enhanced visualization capabilities, the technology has the potential to broaden applications for many innovative cardiac treatment technologies that require precise visualization to deliver effective outcomes.
As cardiac procedures continue to advance in complexity, technologies like Verafeye that offer improved visualization and navigation will likely play an increasingly important role in enhancing procedural success rates and patient outcomes.
