LUMA Vision's VERAFEYE Gains FDA Approval, Revolutionizing Cardiac Imaging with 2D and 4D Visualization

LUMA Vision Secures FDA Approval for Revolutionary Cardiac Imaging Technology

LUMA Vision Ltd., known for its cutting-edge advancements in the realm of cardiac imaging and navigation, proudly announces the FDA clearance of its latest innovation, the VERAFEYE™ Visualization Platform. This state-of-the-art catheter-based imaging system is a game changer for clinicians involved in electrophysiology and structural heart procedures, bringing forth unparalleled real-time visualization capabilities in both two-dimensional (2D) and four-dimensional (4D) formats.

The VERAFEYE system is engineered to provide 360-degree imaging, significantly enhancing the precision and confidence of healthcare providers during complex procedures. This innovative technology facilitates dynamic and high-resolution navigation and visualization, enabling practitioners to view the heart with an impressive depth of detail up to 120 mm from the catheter. This marks a pivotal shift from traditional imaging systems that typically offer only 2D views, often limiting clinicians' ability to comprehensively understand the cardiac anatomy from diverse perspectives during procedures.

Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai, expressed enthusiasm about the system's potential, stating, "Our clinical experience with VERAFEYE is exciting, with the potential to simplify procedural workflow and efficiency. Real-time visualization and rapid creation of cardiac anatomy can facilitate complex procedures with greater simplicity."

According to Fionn Lahart, CEO of LUMA Vision, the approval sheds light on the significant impact that VERAFEYE can have across a variety of cardiovascular applications, including cardiac arrhythmias and left atrial appendage closure. "This achievement is a testament to our team's dedication to revolutionizing cardiac navigation technology. We believe that VERAFEYE will substantially enhance patient care and clinical outcomes," Lahart remarked.

The VERAFEYE system's unique capability to deliver real-time volumetric images, complemented by advanced magnetic navigation features, empowers clinicians to make informed decisions during procedures. This enhancement not only potentially reduces procedure times but also minimizes risks for patients, showcasing a strong commitment to safety and efficacy in cardiac healthcare.

Dr. Anish Amin, System Medical Chief for Cardiac Electrophysiology at OhioHealth Heart and Vascular, labeled the approval of VERAFEYE as a groundbreaking advancement in cardiac imaging. He noted, "VERAFEYE's imaging capabilities showcase a critical path forward in precision imaging, paving the way for advancements in care standards."

LUMA Vision, a private medical device company with its roots in Dublin, Ireland, and Munich, Germany, specializes in developing innovative technologies aimed at addressing significant clinical needs globally. The VERAFEYE platform is designed to create a comprehensive 360-degree view of the heart, allowing for superior navigation and imaging of all structures surrounding the catheter. As a company, LUMA Vision remains steadfast in its mission to enhance healthcare quality and outcomes through groundbreaking solutions.

For those seeking further information on LUMA Vision and its innovative VERAFEYE technology, the company invites you to explore their website at www.lumavision.com.

In summary, the FDA's approval of the VERAFEYE Visualization Platform stands as a remarkable milestone, marking a new era in cardiac imaging technology that promises to transform clinical practices and improve patient outcomes in the cardiovascular healthcare sector.