Luma Vision has won FDA clearance to expand the capabilities of its Verafeye cardiac ablation procedure intelligence platform.
The privately held, Dublin, Ireland–based medtech plans to launch commercially in early 2027. The news comes about six months after the company said it was expanding its clinical programs after submitting to the FDA.
“By bringing imaging, visualization, navigation and guidance together into a single platform, Verafeye delivers significant clinical impact with virtually no workflow disruption. It’s a new paradigm for guiding arrhythmia procedures, and just the beginning of our procedural intelligence platform, which will be expanded into LAA and structural heart,” Fionn Lahart, CEO and co-founder of Luma Vision, said in a news release posted on Sept. 9.
According to Luma Vision, the clearance is for a system that combines digital anatomy creation, catheter tracking, and guidance on a single platform. The goal is to reveal anatomy in real time and analyze it as the procedure unfolds. The physician receives guidance to every target along the way.
Verafeye includes:
- Imaging — a single 360° imaging catheter to capture raw ultrasound data and construct real-time 2D and 3D anatomy of the heart;
- Visualization — a live anatomical map of the heart, valves, great vessels, and surrounding structures;
- Navigation — continuous tracking of both the imaging and ablation catheters;
- Guidance — physicians mark locations directly on the anatomical model as ablation therapy is delivered.
“What stands out about Verafeye is its ability to combine real-time imaging, visualization, and catheter tracking into a single integrated AI-driven platform,” said Dr Devi Nair, chief of cardiac electrophysiology and research at St. Bernards Healthcare and Arrhythmia Research in Jonesboro, Arkansas. “Rather than requiring physicians to piece together information from multiple sources, the system continuously provides anatomical and procedural context in real time without the need for repositioning of the imaging catheter. That represents an important step toward a more intelligent and connected approach to guiding cardiac procedures.”
