Imricor Achieves CE Mark Approval for Advantage-MR System Under New MDR

Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:IMR) ) has provided an announcement.

Imricor Medical Systems, Inc. has received CE mark certification for its Advantage-MR EP Recorder/Stimulator under the European Union’s new Medical Device Regulation (MDR). This approval follows the earlier certification of its second-generation Vision-MR Ablation Catheter. The company plans to launch these products commercially in June across the EU, marking a significant transition from the old directive to the new MDR. This regulatory achievement positions Imricor to phase out its first-generation products and replace them with the newly approved devices, potentially enhancing its market presence and operational capabilities in the European medical device sector.

More about Imricor Medical Systems, Inc. Shs Chess Depository Interests Repr 1 Sh

Imricor Medical Systems, Inc. is a leader in developing MRI-compatible products for cardiac catheter ablation procedures. The company aims to enhance interventional medical procedures by enabling them to be performed under real-time MRI guidance, offering improved imaging capabilities over traditional x-ray fluoroscopy. Imricor’s primary product, the Vision-MR Ablation Catheter, is designed to increase success rates and ensure faster and safer treatments. The company has secured approvals in the EU, KSA, and New Zealand and is pursuing further regulatory approvals in the U.S. and other regions.

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