Imricor Advances U.S. Market Entry with Vision-MR Diagnostic Catheter Submission

Imricor Medical Systems, Inc. (ASX: IMR) has submitted its Vision-MR Diagnostic Catheter for FDA 510(k) approval, marking another milestone in its mission to revolutionize cardiac ablation. Designed for use under real-time MRI guidance, the catheter is a key element of Imricor’s suite of MRI-compatible electrophysiology devices. This filing comes shortly after last month’s 510(k) submission of NorthStar, the world’s first MRI-native 3D mapping and guidance system.

Together, these products represent critical steps toward FDA clearance of the company’s full interventional cardiac MRI (iCMR) platform, which could open access to the sizable U.S. market. CEO Steve Wedan emphasized that the submission brings Imricor closer to delivering a fully integrated, radiation-free platform for physicians and patients. With both NorthStar and Vision-MR now under regulatory review, the company is well positioned to transform how cardiac ablation procedures are performed in the United States.

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