The US Food and Drug Administration (FDA) has cleared LUMA Vision’s Verafeye catheter-based imaging system.
Verafeye is a four-dimensional (4D), ultrasound-based cardiac visualisation and navigation platform that generates a 360-degree view of the heart. The platform combines the Dublin-headquartered company’s proprietary catheter sensor with advanced digital imaging and deep learning to provide real-time guidance during cardiac surgery.
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Traditional imaging catheters are only capable of two-dimensional (2D) imaging, thereby limiting clinicians’ ability to view cardiac anatomy from all angles during procedures. Verafeye’s ability to capture 4D images, which update in real-time and can be captured from up to 120mm away, thereby advances heart navigation and visualisation during the likes of structural heart and electrophysiology procedures, and eliminates the need for external systems such as X-ray or CT scanners.
According to LUMA, the Verafeye platform’s provision of real-time, volumetric images of the heart, combined with magnetic navigation, will enable clinicians to make more informed decisions, potentially reduce procedure time and minimise risks.
LUMA Vision CEO Fionn Lahart commented: “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.”
Dr Anish Amin, system medical chief for cardiac electrophysiology at OhioHealth Heart and Vascular, said that Verafeye’s imaging capabilities demonstrate a “necessary path forward” in precision imaging and a strong foundation to further advance the standard of care.
In support of the FDA clearance and proceeding commercialisation activities for Verafeye, LUMA wrapped a $22m Series A3 financing round in 2023, which featured participation from backers including EQT Lifesciences, ABV Uni Fund, imec.xpand, Atlantic Bridge Growth Fund and Bayern Kapital.
Elsewhere in the electrophysiology field, this month Johnson & Johnson’s Shockwave Medical commenced the multicentre, prospective FORWARD CAD investigational device exemption study of the Javelin coronary intravascular lithotripsy catheter for treating “difficult-to-cross”, calcified coronary lesions.
The market for Pulsed Field Ablation, a technique used in cardiac electrophysiology, exceeded $500m in 2024, as per GlobalData analysis. The current main players in the space are Medtronic and Boston Scientific, with their respective PulseSelect and FARAPULSE PFA systems.
