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Imricor Medical Systems Inc (ASX:IMR)

ALERT: Price-sensitive ASX Announcement for IMR
Current share price for IMR : $1.840 0.16 (9.52%)+
Announcement
Release
11 Jun 2026 8:55AM
Price at Release
$1.680
Full Release
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Summary
Imricor Medical Systems Inc has announced the submission of the third module of its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). This module, which is part of a four-module submission process, includes extensive non-clinical bench testing results for products such as the Vision-MR Ablation Catheter 2.0, RF-5000 Ablation Generator, and RF-5000 Irrigation Tubing Set. Imricor's regulatory strategy involves a modular review process to streamline the FDA's evaluation of its innovative interventional MRI technologies. The submission marks a significant milestone in seeking U.S. approval for these cardiac ablation devices under real-time MRI guidance, particularly targeting the treatment of type I atrial flutter. Imricor is simultaneously pursuing multiple FDA clearances via the 510(k) pathway for other devices in its portfolio.
Key Points
  • Submission of the third PMA module to the FDA.
  • Module covers non-clinical bench testing.
  • Products include Vision-MR Ablation Catheter 2.0 and RF-5000 Ablation Generator.
  • PMA application seeks approval for treating type I atrial flutter.
  • Part of a modular review process with the FDA.
  • Concurrent pursuit of multiple device clearances via the 510(k) pathway.
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.