Imricor advances US approval path after clean FDA catheter review
Imricor has completed FDA review of the largest module in its US Premarket Approval application, with no deficiencies found in its ablation catheter or irrigation tubing. One operating-system issue remains for the RF-5000 System, but the company says it has already updated the software and is preparing its response.
- FDA completes review of Imricor’s largest PMA module
- No deficiencies identified for the Vision-MR Ablation Catheter 2.0 or irrigation tubing
- One RF-5000 System deficiency relates to outdated third-party operating-system support
- Module 3 remains open pending FDA acceptance of Imricor’s response
- Module 4 submission targeted for November
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FDA Review Advances Imricor’s US Approval Path
Imricor Medical Systems, Inc. (ASX:IMR) has cleared a substantial regulatory hurdle in the United States, with the FDA completing its review of the third module of the company’s Premarket Approval application. The module covers the non-clinical testing for the Vision-MR Ablation Catheter 2.0, the RF-5000 System and the RF-5000 Irrigation Tubing Set.
The result was broadly favourable: the FDA identified no deficiencies in the ablation catheter or irrigation tubing set. The sole issue concerns the RF-5000 System’s third-party software operating system, which was no longer under Long-Term Support from its manufacturer.
Single Software Deficiency Keeps Module 3 Open
Imricor says it has already updated the operating system to a version covered by Long-Term Support and is preparing its response to the FDA. Module 3 is therefore not formally closed yet; closure depends on the regulator accepting that response.
The module was submitted on 11 June and is the largest and most technically detailed part of the PMA, spanning product performance, sterile shelf life, packaging integrity, software and cybersecurity testing, electrical safety, electromagnetic compatibility, magnetic-resonance safety and usability. The outcome follows the Imricor is targeting submission of Module 4 in November. If that timetable is met, it would complete the company’s planned PMA submissions, although it would not itself amount to FDA approval of the overall application. Chief executive Steve Wedan said the company was progressing “methodically” through the PMA and described the software issue as one it had already addressed. The next meaningful milestones are narrower but important: acceptance and closure of Module 3, submission of Module 4 and the FDA’s subsequent assessment of the complete application.November Submission Would Complete PMA Modules
Bottom Line?
The largest PMA module has produced only one identified deficiency, but Imricor still needs FDA acceptance of its software response and review of the final module before US approval is secured.
Questions in the middle?
- Will the FDA accept Imricor’s response and formally close Module 3 without further requests?
- Can Imricor submit Module 4 in November as targeted?
- What additional review steps will remain before the complete PMA application can be decided?
Sources
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FDA Completes Review of Third PMA Module (opens in a new tab)Official market announcement. Imricor Medical Systems Inc · 8 Oct 2026 · imricor.com
