IMR.ASX: Submission of the Third PMA Module to the US FDA for Review

Submission of the Third PMA Module to the US FDA for Review

Stock	Imricor Medical Systems Inc (IMR.ASX)
Release Time	11 Jun 2026, 8:55 a.m.
Price Sensitive	Yes

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Imricor Submits Third PMA Module to FDA for MR Cardiac Ablation Tech

Key Points

Imricor submitted the third PMA module to the FDA
Module 3 includes non-clinical bench test results
Vision-MR Ablation Catheter 2.0, RF-5000 Generator, and Tubing Set included
Module 4 will cover clinical data from the VISABL-AFL trial
Aim to achieve FDA approval for iMR cardiac ablation therapy

Full Summary

Imricor Medical Systems, Inc. has submitted the third module of its four-module Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA). The third module comprises non-clinical bench testing results for the Vision-MR Ablation Catheter 2.0, RF-5000 Ablation Generator, and RF-5000 Irrigation Tubing Set. These bench tests include product performance, sterile shelf life, packaging integrity, software testing, electrical safety, electromagnetic compatibility, magnetic resonance safety, and usability. The company is executing a modular review process with the FDA to achieve a more streamlined review process. Imricor's Chair and CEO, Steve Wedan, expressed that this submission represents years of design, manufacturing, and testing of the most sophisticated interventional MR tools in existence.