Imricor completes its 510(k) filings with final NavTrac submissions to the FDA
Imricor Medical Systems (ASX: IMR) has submitted its NavTrac and NavTrac-MR® Steerable Introducers for market clearance under the U.S. Food and Drug Administration’s (FDA’s) 510(k) premarket notification pathway.
With these submissions, every Imricor device following the 510(k) pathway has now been either cleared by, or submitted for clearance to, the FDA. In total, the company has completed 14 of the 15 FDA submissions required to establish its full product platform for commercialisation in the U.S., described as “the world’s largest electrophysiology market.”
The filings were lodged on 20 July 2026 (Melbourne) and 19 July 2026 (Minneapolis), continuing the strong regulatory momentum built over the past six months. Across all its submissions to date, Imricor has filed more than 50,000 pages of product and regulatory documentation with the agency.
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What the NavTrac submissions add to the platform
The NavTrac and NavTrac-MR are steerable introducer sets, each comprising a bi-directionally-steerable sheath and an associated vascular dilator. These products are used to introduce and guide a range of cardiovascular catheters into the heart.
The two versions are distinguished by their intended lab environment:
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NavTrac — supplied with a standard dilator for use in x-ray cath lab environments.
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NavTrac-MR — comes with a dilator containing MR active tracking coils for use in iMR lab environments.
The NavTrac-MR Cable was also submitted today. Together, these devices complete the 510(k) filings suite.
Regulatory scorecard — where each pathway stands
Imricor is progressing across three regulatory fronts: Europe (approved), the U.S. 510(k) pathway (fully filed), and the U.S. PMA pathway (in progress). Each carries a distinct status.
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Europe: the full technology platform is approved, with all 8 products CE-marked and commercial under EU MDR.
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U.S. 510(k): the full suite is now filed, with 6 clearances granted and 5 submissions under FDA review, including the three NavTrac-MR devices submitted today.
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U.S. PMA: modules 1, 2 and 3 have been submitted, with only module 4 remaining before the full PMA filing is complete.
NorthStar and the Vision-MR Diagnostic Catheter were cleared for adult use in January 2026 and for pediatric use earlier this month (July 2026).
The NorthStar FDA clearance in January 2026 marked Imricor’s first approved MRI-native 3D cardiac mapping system in the United States, establishing the foundational cleared device around which the broader platform is now being built.
| Geography | Pathway | Status | Progress | Detail |
|---|---|---|---|---|
| Europe | Med Dev Reg / EU MDR | Approved | 8 of 8 | Full technology platform CE-marked and commercial across Europe. |
| United States | 510(k) | Filed | 11 of 11 | 6 clearances granted; 5 submissions under FDA review, including three NavTrac-MR devices. |
| United States | PMA | In progress | 3 of 4 | Modules 1, 2 and 3 submitted; only module 4 remains before the full PMA filing is complete. |
Why the iMR transition matters
Imricor’s core mission is to enable interventional cardiac procedures to be performed under real-time magnetic resonance (MR) guidance, rather than under x-ray fluoroscopy, taking advantage of MR’s superior imaging capabilities.
Achieving this required an entire portfolio to be re-invented. Every tool and system used in the lab had to be re-developed for use with MRI, which explains why so many separate regulatory submissions were necessary to bring the full platform to market.
The pediatric application carries a distinct clinical rationale. Eliminating x-ray exposure for children is a notable advantage, and according to the company, the economics of performing cardiac catheterisations with NorthStar in an iMR lab are compelling for hospitals.
For investors, this context clarifies why 15 submissions were required and why completing the 510(k) filings represents a significant milestone for investors.
Building a U.S. installed base ahead of full ablation approval
Following the recent pediatric NorthStar clearance, Imricor reports it is well advanced in its sales process with several U.S. pediatric sites. Management expects these pediatric sites to set the stage for a broader rollout across both pediatric and adult hospitals in the United States.
The pediatric NorthStar clearance opens Imricor to a market of over 250 U.S. children’s hospitals, with the company having already received inbound interest from pediatric facilities following its adult clearance earlier in the year.
The strategic sequencing is designed to establish an installed base of iMR labs in the U.S. today. Many of these labs are expected to become ablation sites as the broader portfolio gains approval.
Steve Wedan, Chair and CEO
“Submitting the NavTrac family of steerable introducers completes our 510(k) filings and brings us another step closer to delivering our full platform to the U.S. market. It is a significant milestone for the entire Imricor family, which includes you, our investors.”
Reflecting on the scale of the undertaking, Wedan noted that enabling a transition from x-ray cath labs to iMR labs required all the tools and systems in the lab to be re-invented for use with MRI. In his personal view, drawing on 36 years of developing medical devices, he said he does not recall ever seeing something as ambitious as this.
What comes next
With the 510(k) suite now fully filed, attention turns to the remaining disclosed milestones.
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510(k): clearance decisions on the 5 submissions currently under FDA review are pending.
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PMA: only module 4 remains before the full PMA filing is complete.
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Commercial: Imricor is progressing sales into U.S. pediatric sites and working to establish an installed base of iMR labs.
No specific clearance dates have been disclosed. Completion of the 510(k) filings marks the near-conclusion of a multi-front regulatory programme, with 14 of the 15 required submissions now lodged with the FDA and the final PMA module the remaining step before the full platform is submitted for U.S. commercialisation.
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