Imricor Medical Systems (ASX:IMR) Receives CE Mark Approval for Advantage-MR System
Regulatory Approval
Imricor Medical Systems has obtained CE Mark certification for its Advantage-MR EP Recorder/Stimulator under the European Union’s new Medical Device Regulation (MDR). This approval follows the February 2025 CE Mark certification of the company’s second-generation Vision-MR Ablation Catheter.
Commercial Launch
The commercial launch of the second-generation Vision-MR Ablation Catheter and the new Advantage-MR system is scheduled for June across both new and existing sites in the EU.
Executive Comments
Chair and CEO Steve Wedan stated, “As of today, our entire commercial product portfolio in Europe is approved under MDR. This was a huge undertaking over the past several years to transition from the old European Medical Device Directive rules to the new, more stringent Medical Device Regulations. Our Vice President of Regulatory and Quality, Jennifer Weisz, has built a world-class team, and that team continues to deliver approvals for multiple products across multiple geographies, all with varying regulations and requirements. During this regulatory transition, we also took the opportunity to significantly improve our Vision-MR Ablation Catheter, and early feedback from physicians who have used the new second-generation catheter in our VISABL-AFL and VISABL-VT clinical trials has been very positive, noting improved manoeuvrability characteristics and robustness. We will soon commence phasing out the first generation products from the market, replacing them with these new MDR CE mark approved devices.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
This article was generated using GPT-4o mini, a Large Language Model (LLM), to generate summaries of investing news. While AI is generating the content, we know better than to blindly trust our future robot overlords, and every article is edited and fact-checked by an editor holding the appropriate credentials. The Motley Fool Australia stands behind the work of our editorial team and takes ultimate responsibility for the content of everything published by The Capital Club.