Highlights

  • Imricor’s NorthStar® receives FDA clearance as the first MRI-native 3D guidance system.
  • NorthStar marks Imricor’s first capital equipment and software-focused product approval in the U.S.
  • The clearance positions NorthStar as a central platform for multiple MRI-guided procedures.

FDA Clearance for NorthStar®
Imricor Medical Systems, Inc. (ASX:IMR) announced on 29 January 2026, that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for its NorthStar® Mapping System under the premarket notification process. This clearance makes NorthStar the first and only MRI-native 3D mapping and guidance system approved for use in the United States.

The approval follows closely after Imricor’s earlier 510(k) clearance for its Vision MR® Diagnostic Catheter, strengthening the company’s regulatory footprint in the U.S., the largest market for electrophysiology procedures.

Market and Product Positioning
NorthStar is designed as the central hub for interventional cardiac MRI labs (iCMR). The system integrates diagnostic cardiac electrophysiology and ablation procedures while offering guidance capabilities for other MRI-based interventions. Its software-centric design represents a shift toward a more technology-driven platform within the company’s product portfolio.

The FDA clearance enables Imricor to commercially market NorthStar across the U.S., expanding the availability of MRI-guided electrophysiology procedures. The company expects additional regulatory clearances and approvals for its broader MRI-guided platform throughout the calendar year.

Stock Performance
Imricor shares traded at AUD 1.98, down 3.41% on 30 January 2026.