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Highlights
- Imricor receives CE Mark under new EU regulations
- Launch planned in June across Europe
- Entire commercial portfolio now MDR-certified
Imricor Medical Systems (ASX:IMR) has secured a significant milestone with the CE Mark approval of its Advantage-MR EP Recorder/Stimulator system, granted under the European Union’s updated Medical Device Regulation (MDR). This achievement follows the earlier CE Mark certification, received in February 2025, for the company’s second-generation Vision-MR Ablation Catheter. With both approvals now in place, the company is set to roll out its advanced electrophysiology (EP) offerings across the European market.
The upcoming commercial launch, scheduled for June, will see both the second-generation Vision-MR Ablation Catheter and the newly approved Advantage-MR system introduced across existing and new clinical sites in the EU. This marks a major step forward for Imricor as the company completes the transition of its entire product suite to comply with the EU's more rigorous MDR standards.
Chair and CEO Steve Wedan noted that achieving MDR approval across the entire commercial portfolio was a multi-year process involving extensive regulatory groundwork. Highlighting the leadership of Vice President of Regulatory and Quality, Jennifer Weisz, Wedan emphasized the coordinated efforts required to meet compliance across diverse international regulatory landscapes.
Alongside regulatory alignment, Imricor used the opportunity to enhance the design and performance of its flagship Vision-MR Ablation Catheter. Feedback from physicians participating in the VISABL-AFL and VISABL-VT clinical trials has been encouraging, particularly praising improvements in catheter manoeuvrability and durability. These enhancements are expected to support greater procedural efficiency and patient outcomes in cardiac ablation therapies.
With both key products now approved under MDR, Imricor is preparing to phase out its first-generation systems. The replacement with upgraded devices is aimed at aligning with modern regulatory standards while offering healthcare providers the benefits of improved technology.
The dual CE Mark approvals not only strengthen Imricor’s regulatory standing in Europe but also position the company for deeper integration into MRI-guided cardiac ablation workflows. This progress reinforces its strategic vision of transforming how cardiac electrophysiology procedures are performed across global markets.
As European clinics adopt these next-generation systems, Imricor’s growing footprint under MDR compliance highlights the company's commitment to innovation and quality in the medical technology space.
