LUMA Vision’s 4D Cardiac Imaging Catheter Gets FDA Approval

LUMA Vision has received FDA clearance for Verafeye, its catheter-based, 4D ultrasound imaging system for cardiac procedures. Unlike traditional 2D catheters, Verafeye offers real-time, 360-degree, volumetric imaging, improving heart visualization up to 120mm away without the need for external systems like X-ray or CT.

The Dublin-based company combines proprietary catheter sensors with advanced digital imaging and AI-driven navigation, supporting more precise, informed decisions during electrophysiology and structural heart procedures. LUMA believes Verafeye marks a new era in intracardiac imaging, with potential to reduce procedure time and risks.

To support FDA clearance and commercial rollout, LUMA secured a $22 million Series A3 funding round in 2023, with backing from EQT Lifesciences, Atlantic Bridge, and others.

This development comes as cardiac imaging sees broader innovation, including Johnson & Johnson’s new study on the Javelin catheter for complex coronary conditions.

16-04-2025