LUMA Vision Ltd., an innovative leader in advanced cardiac imaging and navigation, has announced the FDA clearance of its VERAFEYE™ Visualisation Platform. This novel catheter-based imaging system provides real-time, two and four-dimensional, 360-degree visualisation, 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 visualisation 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 visualisation with enhanced depth and clarity.

"Our clinical experience with VERAFEYE is exciting, with the potential to simplify procedural workflow and efficiency. Real-time visualisation and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity," said Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the VERAFEYE system.

Fionn Lahart, CEO, at LUMA Vision, expressed excitement about the technology's potential and said, "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."

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

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 visualisation to deliver effective treatment. By providing real-time, volumetric images of the heart in combination with magnetic navigation, the interactive visualisation of the VERAFEYE system enables clinicians to make more informed decisions, potentially reducing procedure time and minimising risks.