By Digifin Pty Ltd · About this coverage
Key Points
- FDA completed review of PMA Module 3, the largest module, covering non-clinical bench testing
- No deficiencies for the Vision-MR Ablation Catheter 2.0 or the RF-5000 Irrigation Tubing Set
- One deficiency: RF-5000 System operating system no longer under Long-Term Support
- Operating system already updated; Module 3 closes once the FDA accepts the response
- Module 4 submission targeted for November, completing all submissions
About Imricor (ASX:IMR)
Imricor Medical Systems, Inc. is an ASX-listed medical device company headquartered in Burnsville, Minnesota, in the United States. It develops and sells devices and capital equipment used to perform cardiac ablation procedures under real-time magnetic resonance imaging guidance.
Imricor (ASX:IMR) disclosed the outcome of the US Food and Drug Administration (FDA) review of the largest module of its Premarket Approval (PMA) application, which found one deficiency the company says it has already addressed, with one module left to submit.
Module 3, submitted on 11 June 2026, covers the non-clinical bench testing for the Vision-MR Ablation Catheter 2.0, the RF-5000 System (ablation generator, irrigation pump and remote unit) and the RF-5000 Irrigation Tubing Set, including product performance, sterile shelf life, packaging integrity, software testing, electrical safety, electromagnetic compatibility, magnetic resonance safety and usability. The FDA identified no deficiencies for the catheter or the tubing set and one for the RF-5000 System: its software operating system was no longer under Long-Term Support from its manufacturer. Imricor says it has already updated the operating system to a version under Long-Term Support and is preparing its response. The release states the manufacturing module has already been closed.
Module 3 will close only once the FDA accepts Imricor's response. Module 4 submission is targeted for November, and the release gives no timing for an FDA approval decision.
Source: Imricor Medical Systems, Inc. (ASX:IMR), 8 October 2026. Summary content supplied by Digifin Pty Ltd.
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