Imricor Medical Systems (ASX:IMR) received 510(k) clearance for its Vision-MR diagnostic catheter under the premarket notification process with the US Food and Drug Administration, according to a Monday filing with the Australian bourse.
The clearance allows the company to commercially market the catheter, which is designed to be used under real-time magnetic resonance imaging guidance, in the US, the filing said
The company expects to obtain multiple regulatory clearances and approvals this year, as per the filing.
Shares rose more than 25% in morning trade on Monday and earlier reached their highest since July 2021.