Luma Vision has announced the expansion of its clinical programme with the first patient enrolments in two additional European studies at Na Homolce Hospital with Vivek Reddy (Mount Sinai, New York, USA) and Petr Neuzil (Na Homolce Hospital, Prague, Czech Republic), as well as at KBC University Hospital with Ante Anic and Anish Amin (both KBC University Hospital, Split, Croatia). These studies are evaluating Luma Vision’s Verafeye 4D navigation and imaging platform for guiding catheter ablation procedures using a range of technologies.
The successful start of these two studies demonstrates the versatility of the Verafeye platform in guiding ablation workflows entirely through live intraprocedural imaging—2D and 4D—and precise digital anatomical models, enabling intuitive and streamlined ablation guidance and navigation, as per a Luma Vision press release.
Patients have been treated with multiple pulsed field ablation (PFA) systems in the studies, which, as stated by Luma Vision, demonstrates the compatibility of the Verafeye system. Using its 360-degree imaging coverage, advanced catheter guidance and ablation workflow support, Verafeye enables efficient single-operator procedures with “unmatched precision”, the company further claims.
The system utilised in these procedures is the latest iteration of Verafeye, for which Luma Vision recently submitted a 510(k) application to the US Food and Drug Administration (FDA), initiating the regulatory approval process. This version will form the basis of the 2026 commercial launch of Verafeye with enhanced indications as an anatomical imaging and guidance system for cardiac electrophysiology procedures, according to Luma Vision.
The company also reports that both of these milestones were highlighted during a joint visit to Luma Vision’s facility in Munich, Germany by Bavaria’s minister for health Judith Gerlach and Ireland’s minister for health Jennifer Carroll MacNeill as part of an event focused on strengthening European collaboration in cardiac healthcare innovation.
“What you are building here with the Verafeye platform is genuinely a world-first technology,” said Carroll MacNeill. “An open platform, AI [artificial intelligence]-driven 4D imaging system designed to help cardiologists see the heart in a way that has never been possible.”
“Luma Vision is a powerful example of European innovation in action—Irish and Bavarian teams working together to develop breakthrough medical technologies,” Gerlach added.
With regulatory clearance and commercial launch anticipated later this year, Luma Vision says it is preparing to scale up across key markets globally. Verafeye’s open imaging and guidance capabilities enable physicians to perform cardiac ablation using their preferred ablation tool while improving procedural speed, efficiency, and precision—and, beyond ablation, the technology is also expected to expand into structural heart interventions, including left atrial appendage closure and valve placements, the company notes.
