Imricor Medical Systems (ASX:IMR) said that its second-generation vision-magnetic resonance ablation catheter to be used for the potential treatment of type 1 atrial flutter has received CE mark certification under the European Medical Device Regulation (MDR), according to a Wednesday filing with the Australian bourse.
The certification received after an on-site audit conducted by IMR's notified body in October 2024 allows the catheter to be manufactured under the MDR, the filing said.
Imricor plans to submit the device for approval by the Australian Therapeutic Goods Administration.
Shares of the company rose almost 4% in recent Wednesday trade.
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