FDA Clears Verafeye 4D Catheter-Based Imaging Platform for Heart Procedures
FDA Clears Verafeye 4D Catheter-Based Imaging Platform for Heart Procedures
Source: Health Imaging
Date: April 16, 2025
Take-Home Messages:
1. FDA Clearance:
• LUMA Vision, a medtech company based in Ireland and Germany, received FDA clearance for its Verafeye Visualization Platform, a catheter-based system for real-time 2D and 4D ultrasound imaging.
• The system is designed to support complex interventional electrophysiology and structural heart procedures.
2. Technology Features:
• Verafeye delivers real-time, multi-angle ultrasound imaging from a catheter tip with a range of up to 120 mm.
• It also supports magnetic tracking and navigation for third-party catheters.
3. Clinical Impact:
• The platform aims to enhance imaging precision and procedural safety in cardiac arrhythmias, left atrial appendage closure, and other structural heart interventions.
• According to Dr. Anish Amin (OhioHealth), it represents a major advancement in intra-procedural cardiac imaging.
4. First-in-Human Use:
• The first clinical use of Verafeye was reported in January 2025 by Dr. Gábor Széplaki at Mater Private Hospital in Dublin, Ireland.
• The system provided full imaging and navigation capability for “single shot” procedures in real-time.Original Link: https://www.healthimaging.com/topics/cardiovascular/fda-clears-luma-verafeye-4d-catheter
