• Imricor has submitted its Vision-MR Diagnostic Catheter for FDA 510(k) approval
• The catheter is designed for use under real-time MRI guidance
• This submission, along with last month's NorthStar 3D mapping system, are steps towards FDA clearance for Imricor's full iCMR suite

Imricor Medical Systems, Inc. (ASX: IMR) has announced that it has submitted its Vision-MR Diagnostic Catheter for approval under the U.S. Food and Drug Administration's 510(k) premarket notification pathway. The Vision-MR Diagnostic Catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and represents another key component of Imricor's full platform of MRI-compatible electrophysiology (EP) devices. This submission follows last month's FDA 510(k) submission of NorthStar, the world's first and only MRI native 3D mapping and guidance system. Together, these submissions are stepping stones toward FDA clearance for the full iCMR suite, ultimately unlocking the large U.S. market. Imricor's Chair and CEO, Steve Wedan, commented that submitting the Vision-MR Diagnostic Catheter is another important step toward the company's goal of transforming cardiac ablation by enabling procedures to be performed in the MRI environment. With NorthStar and the diagnostic catheter now both under FDA review, Imricor is advancing toward its objective of delivering a fully integrated, radiation-free platform to U.S. physicians and patients.

Imricor is pursuing the required regulatory approvals to place its key products, including the Vision-MR Diagnostic Catheter and NorthStar 3D Mapping System, on the market in the U.S.

Imricor is focused on obtaining FDA clearance for its full iCMR suite of MRI-compatible EP devices, which would unlock the large U.S. market for the company's radiation-free cardiac ablation platform.