FDA OKs LUMA Vision’s Verafeye 2D/4D Cardiac Visualization

LUMA Vision, a company focused on advanced cardiac imaging and navigation, has earned U.S. Food and Drug Administration (FDA) clearance of its Verafeye visualization platform.

The catheter-based imaging system offers real-time, two and four-dimensional, 360-degree visualization—especially helpful for complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters.

The successful first-in-human use of Verafeye took place in January 2025.

Verafeye merges imaging tech with advanced digital maneuverability so clinicians can capture detailed, four-dimensional images that update in real time. It can reach imaging depths up to 120 mm away from the catheter to provide dynamic, high-resolution navigation and visualization of the heart.

Traditional catheters provide two-dimensional imaging, which can limit the ability to view cardiac anatomy from all angles during a procedure.

“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.”

LUMA Vision hopes Verafeye can help clinicians make more informed decisions by providing real-time volumetric images of the heart in combination with magnetic navigation.

“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,” said LUMA Vision CEO Fionn Lahart. “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.”