LUMA Vision Receives FDA Clearance for VERAFEYE 2D/4D Cardiac Visualization Platform

Real-Time, 360-Degree Imaging Enhances Precision and Confidence in Cardiac Procedures

DUBLIN, April 16, 2025 /PRNewswire/ -- LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, today announced the FDA clearance of its VERAFEYE™ Visualization Platform. This novel catheter-based imaging system provides real-time, two and four-dimensional, 360-degree visualization, significantly enhancing clinician precision and confidence during complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters, which in the future, will further empower clinicians to perform complex procedures with greater precision and control.

The VERAFEYE system combines state-of-the-art imaging technology with advanced digital maneuverability, enabling clinicians to capture highly detailed, four-dimensional images that update in real time. With imaging depths up to 120 mm away from the catheter, it allows for dynamic high-resolution navigation and visualization of the heart, crucial to performing today's advanced electrophysiology and structural heart procedures with a wide variety of technologies. Traditional imaging catheters provide only two-dimensional imaging, often limiting clinicians' ability to view cardiac anatomy from all angles during procedures. The VERAFEYE catheter introduces a new era of intracardiac imaging, allowing for comprehensive, 360-degree visualization with enhanced depth and clarity.

"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."

Fionn Lahart, CEO, at LUMA Vision, expressed excitement about the technology's potential: "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, and this FDA clearance is a testament to their dedication and expertise. We look forward to seeing the positive difference VERAFEYE will make in the lives of patients and healthcare providers alike".

The successful approval of the VERAFEYE system and catheter represents a significant step toward improving procedural workflows and broadening the potential for many of the innovative technologies that need precise visualization to deliver effective treatment. By providing real-time, volumetric images of the heart in combination with magnetic navigation, the interactive visualization of the VERAFEYE system enables clinicians to make more informed decisions, potentially reducing procedure time and minimizing risks.

"The approval of VERAFEYE is a major advancement in intraprocedural cardiac imaging," said Dr. Anish Amin, System Medical Chief for Cardiac Electrophysiology, OhioHealth Heart and Vascular. "VERAFEYE's imaging capabilities demonstrate a necessary path forward in precision imaging and a strong foundation to further advance the standard of care."

About LUMA Vision
LUMA Vision is a privately held, medical device company based in Dublin, Ireland and Munich, Germany. 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

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