Highlights

  • The US FDA has completed its review of Imricor's third Premarket Approval (PMA) module.
  • No deficiencies were identified for the Vision-MR Ablation Catheter 2.0 or the RF-5000 Irrigation Tubing Set.
  • One deficiency related to the RF-5000 System's third-party operating system has already been addressed.
  • Imricor is targeting submission of Module 4 in November 2026, completing all PMA submissions.

Imricor Medical Systems, Inc. (ASX:IMR) has announced that the US Food and Drug Administration (FDA) has completed its review of the third module of the company's Premarket Approval (PMA) application. Module 3 is the largest of the PMA modules and covers all non-clinical bench testing for the company's products.

Scope of Module 3

Module 3 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. The RF-5000 System includes the ablation generator, irrigation pump and remote unit.

The testing spans product performance, sterile shelf life, packaging integrity, software, electrical safety, electromagnetic compatibility, MR safety and usability. Module 3 was submitted to the FDA on 11 June 2026.

FDA Review Outcome

The FDA identified no deficiencies for the Vision-MR Ablation Catheter 2.0 or the RF-5000 Irrigation Tubing Set. One deficiency was identified for the RF-5000 System, as the generator's third-party operating system no longer had long-term support from its manufacturer.

Imricor has already updated the operating system to a supported version and is preparing its response. Module 3 will be closed once the FDA accepts the response.

Chair and CEO Steve Wedan said the outcome is "a Credit to the rigor our engineering and regulatory teams have applied throughout this program."

Path to Final PMA Submission

The Manufacturing module has already been closed. Imricor is targeting submission of Module 4 in November 2026, which would complete all of its PMA submissions.

Wedan said the company is working methodically toward bringing a complete, radiation-free iMR ablation platform to US physicians and patients.

Key Takeaways

  • The FDA has completed its review of Imricor's largest PMA module.
  • Only one deficiency was identified, and the company has already addressed it.
  • The manufacturing module is closed, and Module 3 will close once the response is accepted.
  • Module 4, the final PMA submission, is targeted for November 2026.