• Imricor's first FDA clearance for its VISION-MR Diagnostic Catheter
• Catheter designed for use under real-time MRI guidance
• Clears Imricor to commercially market the device in the US, the world's largest electrophysiology market

Imricor Medical Systems, Inc. (ASX: IMR) announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for the company's VISION-MR Diagnostic Catheter under the premarket notification process. This marks the company's first FDA clearance. The VISION-MR Diagnostic Catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and represents a key component of Imricor's comprehensive platform of MRI-compatible electrophysiology (EP) devices. FDA clearance enables Imricor to commercially market the VISION-MR Diagnostic Catheter in the United States, the world's largest electrophysiology market. This clearance is the first of what the company expects will be multiple regulatory clearances and approvals this calendar year, as Imricor's full MRI guided EP platform is progressively introduced to the market. Imricor's Chair and CEO, Steve Wedan, acknowledged the outstanding work of the entire team in reaching this milestone, noting that getting a company's first device on the US market is an extraordinarily big deal.