LUMA Vision, a medical technology company focused on minimally invasive cardiac procedures, has received US Food and Drug Administration (FDA) clearance expanding the capabilities of its VERAFEYE procedural intelligence platform.

The clearance supports LUMA Vision's development of an integrated cardiac laboratory in which imaging, visualisation, navigation and guidance work together on a single platform. VERAFEYE is designed to provide physicians with continuous, real-time information about cardiac anatomy, devices and therapy delivery during procedures.

The updated platform combines digital anatomy creation, catheter tracking and procedural guidance. It can create three-dimensional models of the left and right atria with CT-like accuracy, allow physicians to visualise and document ablation treatment directly on the anatomical model, and continuously track imaging and ablation catheters using electromagnetic tracking and automated imaging.

VERAFEYE uses a single 360-degree imaging catheter to capture ultrasound data and create real-time two-dimensional and three-dimensional images of the heart. The system builds a live anatomical map covering the heart, valves, great vessels and surrounding structures.

The platform also provides continuous tracking of both imaging and ablation catheters. This is intended to reduce the need for physicians to manually reposition the imaging catheter during procedures and help maintain visibility of the ablation catheter.

During ablation therapy, physicians can mark treatment locations directly on the anatomical model. This provides information on the position of therapy and supports alignment during the procedure.

LUMA Vision is also developing the platform's procedural intelligence capabilities using data from real-world cases. The company plans to expand the system's guidance functions as its database of cardiac anatomy and procedures grows.

The FDA clearance represents another step towards LUMA Vision's planned commercial launch of VERAFEYE in early 2027. The company also intends to extend the platform beyond arrhythmia procedures into left atrial appendage (LAA) and structural heart applications.

 

Source: prnewswire.com

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