LUMA Vision Receives FDA Approval for its Novel VERAFEYE™ Cardiac Imaging Platform

LUMA Vision Ltd., a company specialising in advanced cardiac imaging and navigation, has announced that it has received clearance from the US Food and Drug Administration (FDA) for its VERAFEYE™ Visualization Platform. The new catheter-based system provides real-time, two- and four-dimensional imaging with full 360-degree visualisation. It aims to support improved accuracy and confidence during complex procedures in electrophysiology and structural heart interventions.

VERAFEYE has been designed with future-ready features, including compatibility with magnetic tracking and navigation of third-party catheters. This is expected to allow for even greater precision and control in upcoming procedural techniques.

The system integrates high-resolution imaging technology with enhanced digital control, offering detailed four-dimensional images that refresh in real time. With the ability to image up to 120 mm from the catheter tip, VERAFEYE supports more dynamic and accurate navigation inside the heart. This is particularly valuable in modern heart procedures where traditional two-dimensional imaging may limit visibility.

Unlike standard imaging tools that only offer limited viewpoints, VERAFEYE gives clinicians a full 360-degree view with improved depth and clarity. This allows for a more complete understanding of the cardiac anatomy throughout the procedure.

VERAFEYE’s real-time volumetric imaging, when combined with magnetic navigation, provides a powerful tool for clinical decision-making. This may lead to shorter procedure times and reduced risks during cardiac interventions. The system represents a significant step forward in the evolution of intraprocedural imaging and could play a key role in advancing standards of care in cardiology.