Imricor Medical Systems, Inc. (ASX: IMR) Submits NorthStar for CE Mark Approval
NorthStar CE Mark Submission
Imricor Medical Systems, Inc. (ASX: IMR) has submitted its NorthStar 3D Mapping System for CE Mark approval in Europe. This marks a significant milestone leading to the system’s commercial rollout across existing and new customer sites in Europe and the Middle East.
Accelerated US Approval Process
Due to substantial interest from US hospitals, Imricor is expediting the 510(k) submission for FDA approval of NorthStar. Earlier-than-expected approvals for consumable products are anticipated in the second half of 2025, allowing for an established installed base in the US.
Clinical Advancements for VISABL-VT
The VISABL-VT clinical trial has received ethics approval from Amsterdam UMC, paving the way for the first MRI-guided VT ablation procedure early in 2025. Dr Marco Götte, Director of the Cardiac MRI Research Team, expressed enthusiasm for the potential shift in treatment standards.
Executive Comments
Steve Wedan, Imricor’s Chair and CEO, remarked on the successful year and highlighted the strategic focus on NorthStar’s approval and market introduction. He stated, “With NorthStar in market in Europe and the Middle East, we make it much easier for our sales team to establish new labs.” He anticipates this will amplify procedure volume and ultimately change the standard of care in interventional procedures.
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