FDA completes review of Imricor’s third PMA module with one deficiency
Imricor Medical Systems, Inc. (ASX: IMR) has received notice from the U.S. Food and Drug Administration (FDA) that the FDA has completed its review of Module 3, the largest module of the Company’s Premarket Approval (PMA) submission. The FDA identified a single deficiency, with none identified for the Vision-MR Ablation Catheter 2.0.
The announcement was dated 08 October 2026 in Melbourne (07 October 2026 in Minneapolis). Module 3 was submitted to the FDA on 11 June 2026.
Steve Wedan, Chair and CEO
“Module 3 is the largest and most technically detailed part of our PMA… To complete an FDA review of that scope with a single deficiency, and one we have already addressed, is a credit to the rigor our engineering and regulatory teams have applied throughout this program… we continue to work methodically through each component of the PMA as we advance toward delivering a complete, radiation-free iMR ablation platform to U.S. physicians and patients.”
When big ASX news breaks, our subscribers know first
What Module 3 covered and what the FDA found
Bench testing scope
Module 3 contains the design, execution and results of all non-clinical (so-called “bench”) tests associated with three products: the Vision-MR Ablation Catheter 2.0, the RF-5000 System (comprising the ablation generator, irrigation pump and remote unit), and the RF-5000 Irrigation Tubing Set.
The bench tests include:
- Product performance
- Sterile shelf life
- Packaging integrity
- Software testing
- Electrical safety
- Electromagnetic compatibility
- Magnetic resonance safety
- Usability
Review outcome by product
The FDA identified no deficiencies for two of the three product groups. The single deficiency relates to the RF-5000 System.
| Product | FDA deficiencies | Status |
| Vision-MR Ablation Catheter 2.0 | None | No deficiencies identified |
| RF-5000 Irrigation Tubing Set | None | No deficiencies identified |
| RF-5000 System | One | Third-party software operating system; already updated, response to FDA underway |
Understanding the PMA process and the single deficiency
Premarket Approval is a regulatory pathway for medical devices, and Imricor’s PMA is being submitted in modules. Module 3 is the third of these, and it covers bench testing, which is laboratory testing of the devices themselves rather than testing in patients.
The FDA stated that the deficiency was that the software operating system in the RF-5000 system was no longer under Long-Term Support from its manufacturer. Long-Term Support means the manufacturer continues to provide ongoing updates for that version of the software.
Imricor has already updated the operating system to a version that is under Long-Term Support, and the Company is preparing its response to the FDA. The deficiency requires a response before the FDA accepts and closes the module. The announcement does not indicate when acceptance may occur.
Next steps toward a complete PMA
The announcement sets out the following sequence:
- Imricor’s response to the FDA is underway.
- Upon FDA acceptance, Module 3 will be closed.
- Module 4 submission is targeted for November, completing all submissions.
Wedan noted that the manufacturing module is already closed. The announcement does not specify how many other modules are closed or open.
The closed manufacturing module covers seven devices, and once a PMA module is closed it is not expected to be re-reviewed unless its contents change, which removes that work from end-stage review risk.
For investors, the update shows Imricor advancing toward a complete PMA submission for what Wedan described as a radiation-free iMR ablation platform for U.S. physicians and patients.
Imricor’s products are approved in the European Union, the Kingdom of Saudi Arabia and New Zealand. NorthStar and Vision-MR Diagnostic Catheter are cleared in the US.
Don’t Miss the Next Healthcare Breakout
Join 20,000+ investors getting FREE breaking ASX news within minutes of release, complete with in-depth analysis and the full announcement. Click the “Free Alerts” button at Big News Blast to get healthcare and other non-resource ASX news in your inbox the moment it breaks.