Imricor Medical Systems (ASX: IMR) Clears FDA Manufacturing Module

Imricor Medical Systems has cleared a complex manufacturing component of its US regulatory program for magnetic resonance-guided electrophysiology devices.

The US Food and Drug Administration has accepted and closed the manufacturing module within Imricor’s Premarket Approval submission. The regulator notified the company after completing its evaluation, Imricor said in an announcement dated September 3 in Melbourne.

The decision removes one component from the remaining PMA review, provided its contents do not subsequently change. However, it does not constitute final approval for the products covered by the submission.

Seven Products Under Review

The module covers design, manufacturing and quality processes surrounding seven products. Six are Imricor devices undergoing the FDA’s PMA process.

These include the Vision-MR Ablation Catheter and the RF-5000 Ablation Generator and Pump. The seventh is a third-party product that Imricor plans to distribute.

The review examined design controls and procedures for receiving, inspecting and storing raw materials. It also covered build procedures, process validation and device traceability. Applicable quality-management systems formed part of the assessment.

Imricor described the module as one of the largest and most complex parts of its PMA submission. That reflected both the number of devices and the range of manufacturing controls involved.

How the Modular Process Works

Imricor is using a modular PMA review, rather than submitting every component for assessment at once. Modules addressing different product requirements are lodged and reviewed serially.

Once the FDA accepts and closes a module, it is not expected to revisit that work during the final review. An exception applies if Imricor later changes the module’s contents.

This approach gives the company visibility over completed parts of the regulatory process. It also separates manufacturing assessment from the other modules required for a final FDA decision.

Chair and Chief Executive Officer Steve Wedan said: “Every closed module brings us a step closer to delivering iMR-guided EP to U.S. physicians and their patients.”

Approval Still Requires an Inspection

The next remaining steps include completion of the FDA’s review of all PMA modules. The regulator must also conduct a pre-approval inspection of Imricor’s manufacturing sites.

Final PMA approval remains subject to satisfactory completion of both requirements. Imricor did not provide a timetable for the inspection or a final decision.

The company is also progressing separate 510(k) and PMA pathways across its electrophysiology portfolio. Those processes are intended to support the commercial launch of its EP platform in the United States.

US Position in Context

Imricor develops MR-compatible equipment and single-use devices for procedures performed under real-time magnetic resonance guidance. Its technology is designed as an alternative to procedures guided by X-ray fluoroscopy.

The company’s products are already approved in the European Union, Saudi Arabia and New Zealand. In the US, its NorthStar Mapping System and Vision-MR Diagnostic Catheter have received clearance.

Closure of the manufacturing module therefore advances a broader US regulatory program. The central unresolved issue remains final FDA review, including the required inspection of manufacturing operations.