IMR.ASX: Imricor Submits All Remaining 510(k) Devices to FDA

Imricor Submits All Remaining 510(k) Devices to FDA

Stock	Imricor Medical Systems Inc (IMR.ASX)
Release Time	20 Jul 2026, 9:25 a.m.
Price Sensitive	Yes

This feature provides summaries of price-sensitive announcements for companies followed by users on InvestorPA. The summaries are generated by large language models so please interpret with care.

Imricor Submits All Remaining 510(k) Devices to FDA

Key Points

Imricor has submitted its NavTrac and NavTrac-MR Steerable Introducers to the FDA.
All 15 required FDA submissions for Imricor's U.S. platform are now completed.
Imricor's CEO expects to establish an installed base of iMR labs in the U.S.

Full Summary

Imricor Medical Systems, Inc. has submitted its NavTrac and NavTrac-MR Steerable Introducers to the FDA for market clearance, completing all 15 required FDA submissions to establish its full product platform in the U.S. These steerable introducers are used to guide cardiovascular catheters into the heart and are designed for use in x-ray and MRI environments. The submission follows recent FDA clearances for NorthStar and the Vision-MR Diagnostic Catheter. Imricor's CEO, Steve Wedan, highlighted the company's strong regulatory momentum and anticipated broader rollout in U.S. pediatric and adult hospitals.