Key highlights

  • Imricor shares closed at $1.33 on 12 November 2026, up 4.72%, while the S&P/ASX 200 eased 0.07%.
  • The FDA completed review of the third PMA module, identifying one deficiency relating to the RF-5000 system software operating system, which the company has already updated.
  • The company is targeting submission of its fourth PMA module in November 2026, completing all PMA submissions.

Shares in Imricor Medical Systems Inc (ASX:IMR) closed at $1.33 on 12 November 2026, up 4.72% on the session. The S&P/ASX 200 closed at 9,146.80, down 0.07%. Imricor, based in Burnsville, Minnesota, develops MR-compatible products for interventional procedures performed under real-time magnetic resonance guidance. Its latest update was an announcement dated 8 October 2026 on the FDA's review of its third PMA module, which is about five weeks before the share move.

FDA review of module three

The FDA completed its review of Imricor's third Premarket Approval module, which covers the design, execution and results of non-clinical bench testing for the Vision-MR Ablation Catheter 2.0, the RF-5000 System and the RF-5000 Irrigation Tubing Set. Imricor submitted the module on 11 June 2026. The FDA identified no deficiencies for the catheter or the tubing set, and one deficiency for the RF-5000 System.

The single deficiency

The deficiency related to the software operating system used in the RF-5000 generator, which was no longer under long-term support from its manufacturer. Imricor said it has already updated the operating system to a version under long-term support, and is preparing its response to the FDA. Module three will be closed once the FDA accepts that response.

Next submissions

The company said its fourth PMA module is targeted for submission in November 2026, which would complete all submissions. The Manufacturing module had already been closed. Chair and CEO Steve Wedan described module three as the largest and most technically detailed part of the PMA, covering product performance, shelf life, software, cybersecurity, electrical and MR safety.

Closing thoughts

Imricor shares finished the session up 4.72% at $1.33. The company has moved through the bench testing module of its PMA with a single deficiency, and its next steps are the response to the FDA and the fourth module submission.