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Imricor Medical Systems Inc (ASX:IMR)

ALERT: Price-sensitive ASX Announcement for IMR
Current share price for IMR : $1.920 0.115 (6.37%)+
Announcement
Release
2 Jul 2026 8:33AM
Price at Release
$1.805
Full Release
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Summary
Imricor Medical Systems, Inc. has announced that it received 510(k) clearance from the U.S. FDA to expand the labeling of its NorthStar system and Vision-MR Diagnostic Catheter for pediatric use. This expansion allows the marketing of these devices for use in children and young adults across over 250 children's hospitals in the U.S. The move represents a strategic step in Imricor's U.S. commercialization plan, capitalizing on the pediatric market's need to reduce radiation exposure in medical procedures. Imricor aims to position its iMR-guided procedures as safer alternatives to traditional x-ray-based methods, especially beneficial for pediatric patients with congenital heart defects. The company views this as a precursor to wider adoption of its full electrophysiology platform in adult hospitals. Imricor's CEO highlighted the company's commitment to providing radiation-free procedures for all patient demographics.
Key Points
  • Imricor received FDA 510(k) clearance for pediatric use of NorthStar system and Vision-MR Diagnostic Catheter.
  • Pediatric labeling expansion allows use in over 250 children's hospitals across the U.S.
  • The expansion is part of Imricor's U.S. commercialization strategy.
  • iMR procedures are positioned as a safer alternative by eliminating radiation exposure.
  • The company focuses on the pediatric market's interest in reducing radiation.
  • Imricor aims for broader adoption of its electrophysiology platform in adult hospitals.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.