Imricor Submits NorthStar for U.S. Pediatric Expansion

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Stock Imricor Medical Systems Inc (IMR.ASX)
Release Time 8 Apr 2026, 8:44 a.m.
Price Sensitive Yes
 Imricor Submits NorthStar for U.S. Pediatric Expansion
Key Points
  • Imricor has submitted its NorthStar® Mapping System to the FDA for pediatric label expansion
  • Pediatric label expansion will enable Imricor to proactively market NorthStar to children's hospitals across the U.S.
  • Clearance is expected in the current quarter
Full Summary

Imricor Medical Systems, Inc. (ASX: IMR) is pleased to announce that it has submitted its NorthStar® Mapping System to the U.S. Food and Drug Administration (FDA) for pediatric label expansion via the FDA's Special 510(k) pathway. The submission follows Imricor's announcement in January 2026 that NorthStar had received FDA clearance for use in adult patients. The submission to expand NorthStar to include use with pediatric patients represents another important step in the Company's U.S. commercialization strategy. Imricor has received inbound interest from children's hospitals across the United States following the FDA clearance of NorthStar. The pediatric label expansion is intended to enable Imricor to proactively market NorthStar into this important customer segment and to support the establishment of an installed base in pediatric centres around the U.S. during 2026. There are over 250 children's hospitals in the United States. The Company believes the pediatric market represents an attractive early commercial channel for NorthStar in advance of broader U.S. adoption of Imricor's full EP platform in adult hospitals. Children's hospitals often have a strong interest in reducing radiation exposure for their patients, and as navigation system for use in interventional cardiovascular magnetic resonance (iCMR) procedures, NorthStar may be well suited to adapt and improve iCMR procedure workflows currently performed with only stock MRI system interfaces. Importantly, the Company can already sell NorthStar to Children's hospitals who have proactively contacted the Company. If cleared, the pediatric label expansion would allow Imricor to proactively market NorthStar for use in pediatric cases, broadening the addressable market for the system and strengthening the Company's commercial momentum in the United States. Clearance is expected in the current quarter.

Outlook

Submitting NorthStar for a label expansion into pediatrics is an exciting and practical step to accelerate Imricor's U.S. commercialization strategy. Establishing an installed base in children's hospitals has the potential to generate revenue, expand awareness of Imricor's technology, and position the company strongly as it continues working toward broader rollout of its full EP platform in adult hospitals.