Imricor Medical Systems (ASX:IMR) said that the US Food and Drug Administration (FDA) has cleared its NorthStar Mapping System, marking the company's second FDA clearance in January, following earlier approval of the VisionMR Diagnostic Catheter, according to a Thursday filing with the Australian bourse.
The approval allows the company to market NorthStar in the US, establishing it as the core system of interventional cardiac magnetic resonance imaging (MRI) labs, with further approvals anticipated as the company expands its MRI-guided electrophysiology platform, the filing added.
The company's shares rose 12% in recent Thursday trade, earlier hitting a five-year high.