Luma Vision’s Verafeye 2D/4D Cardiac Visualization Platform Receives FDA Clearance

April 16, 2025—Luma Vision Ltd., an Ireland- and Germany-based developer of cardiac imaging and navigation technology, announced the FDA clearance of its Verafeye visualization platform.

Verafeye is a catheter-based imaging system that provides real-time, two-dimensional (2D) and four-dimensional (4D), 360º visualization for complex electrophysiology and structural heart procedures. With imaging depths up to 120 mm away from the catheter, the Verafeye system allows for dynamic high-resolution navigation and visualization of the heart, stated the company. Additionally, the Verafeye system is prepared for magnetic tracking and navigation of third-party catheters, according to Luma Vision.

“Our clinical experience with Verafeye is exciting, with the potential to simplify procedural workflow and efficiency,” commented Shephal Doshi, MD, in the company’s press release. “Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity.”

Anish Amin, MD, added, “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.”

Dr. Doshi, who served as an investigator of the Verafeye system, is Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai in Los Angeles, California. Dr. Amin is System Medical Chief for Cardiac Electrophysiology at OhioHealth Heart and Vascular in Columbus, Ohio.