• 2nd generation Vision-MR Ablation Catheter receives CE mark certification under new European MDR regime
• Imricor's manufacturing certificate updated to include MDR compliance
• Imricor expects to submit new MDR-compliant 2nd generation catheter for TGA approval in Australia

Imricor Medical Systems, Inc. (ASX: IMR) has announced that the 2nd generation Vision-MR Ablation Catheter has received CE mark certification under the new, more stringent, European Medical Device Regulation (MDR), for the treatment of type 1 atrial flutter (AF). The 2nd generation Vision-MR Ablation Catheter is the catheter involved in both the VISABL-VT clinical trial in Europe and the VISABL-AFL clinical trial supporting FDA approval in the US. The company has received the final approval certificate to enable manufacturing of the 2nd generation Vision-MR Ablation Catheter under MDR, following an on-site audit conducted by Imricor's Notified Body in October 2024. With the successful CE mark certification under MDR, the company expects to submit the 2nd generation Vision-MR Ablation Catheter for approval by the Australian Therapeutic Goods Administration (TGA). Imricor's Chair and CEO, Steve Wedan, commented that the 2nd generation catheter incorporates performance and cost improvements developed by Imricor's engineers over the past decade and is designed to be the company's future ablation catheter globally.