Imricor Receives FDA Clearance for NorthStar MRI Mapping System

Imricor Medical Systems Inc. (ASX: IMR) has announced that the United States Food and Drug Administration (FDA) has granted 510(k) clearance for its NorthStar Mapping System. This milestone marks Imricor’s second FDA approval this month and the first clearance for a capital equipment and software-centric product from the company in the US market.

NorthStar is the first and only MRI-native three-dimensional mapping and guidance system to receive FDA clearance. It is positioned as the foundational software platform for a broad pipeline of current and future MRI-guided procedures. The system is intended to be the central hub in interventional cardiac MRI laboratories, supporting diagnostic electrophysiology and ablation procedures, as well as other MRI-guided interventions.

The clearance enables Imricor to commercially market NorthStar in the United States, the largest electrophysiology market globally. This regulatory achievement is a key part of Imricor’s strategy to progressively roll out its full MRI-guided electrophysiology platform. CEO Steve Wedan highlighted the significance of this milestone, noting that it builds on two decades of development in MRI-compatible devices, and underscores the company’s commitment to safer, faster, and more cost-effective treatments.

NorthStar also marks the beginning of Imricor’s transition into a software-driven future. The platform has been designed with AI in mind, offering potential for long-term scalability and adaptability across a wide range of applications.