Imricor Medical Systems (ASX:IMR) submitted the NorthStar 3D mapping system for CE Mark approval in Europe, marking the final stage before commercial rollout across Europe and the Middle East, according to a Monday filing with the Australian bourse.
The company anticipates US Food and Drug Administration approval for its consumable ablation tools in the second half of 2025 with NorthStar's expedited approval processes in Europe and the US, the filing said.
Meanwhile, the first-in-human ventricular tachycardia ablation guided by real-time magnetic resonance imaging will take place next year, according to the filing.
Shares rose nearly 7% in morning trade Monday.
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