Dublin, Ireland-based Luma Vision develops the Verafeye 4D navigation and imaging platform. The company designed Verafeye to guide catheter ablation therapy. That includes pulmonary vein isolation, posterior wall isolation and ablation of the cavotricuspid isthmus. The platform initially won FDA clearance in April 2025.
The company now reports the enrollment of patients in two additional European studies. One study takes place at Na Homolce Hospital in Prague with Dr. Vivek Reddy and Dr. Petr Neuzil. The other takes place at KBC University Hospital in Split with Dr. Ante Anic and Dr. Anish Amin.
Both studies evaluate the latest iteration of Verafeye in a range of ablation procedures. They evaluate the platform’s ability to guide ablation workflows entirely through live intra-procedural imaging (2D and 4D) and precise digital anatomical models. Investigators treated patients using multiple pulsed field ablation (PFA) systems, demonstrating Verafeye’s compatibility. The company has previously demonstrated its platform’s compatibility with the CardioFocus QuickShot Nav PFA platform.
Luma Vision, an Ireland-based company, continues making inroads in the U.S. IDA Ireland, the foreign investment arm for the Irish government, and Enterprise Ireland both shared the government’s view on medtech’s growth in the country in 2025 interviews with MassDevice.
According to Luma Vision, it expects FDA clearance for its latest Verafeye version ahead of a planned commercial launch this year. It hopes to garner clearance for enhanced indications as an anatomical imaging and guidance system for cardiac electrophysiology procedures.
Once it secures regulatory clearance and begins its launch, the company plans to scale up in key markets globally. Beyond ablation, it also expects to expand into structural heart interventions, including left atrial appendage closure (LAAC) and valve placements.
“Enterprise Ireland is committed to supporting Irish companies to start, grow and scale,” said Jenny Melia, CEO of Enterprise Ireland. “We have supported Luma Vision from its earliest stages, and today’s milestones with the Verafeye platform demonstrate exactly why this is a breakthrough platform: co–developed across Irish and Bavarian teams, backed by shared European investment, and now delivering real clinical impact.”
