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Imricor starts US launch of NorthStar iMR system after paediatric FDA clearances

🇺🇸 Imricor Medical Systems, Inc. · Fri 13 Nov 2026

The MRI-guided cardiac catheterisation company reports its first US sales, two children's hospital customers and extended FDA paediatric labelling in its third-quarter results.

Imricor Medical Systems has begun selling its NorthStar iMR cardiac catheterisation system in the United States, according to its quarterly report for the period ended 30 September 2026, dated 13 November 2026. The first two customers are Rady Children's in San Diego and Children's Medical Center Dallas.

The US Food and Drug Administration cleared paediatric label expansions for both the NorthStar system and the Vision-MR Diagnostic Catheter. The company did not provide further detail in the summary available on the clearances.

On the ablation programme, the FDA accepted and closed the manufacturing module of the premarket approval (PMA) application for the Vision-MR Ablation Catheter. Imricor also reported that it had completed 510(k) submissions for its NavTrac introducers. A PMA is the FDA's most stringent route for high-risk devices and is often submitted in modules, while a 510(k) shows substantial equivalence to a legally marketed device.

Financially, quarterly revenue was US$188k and cash stood at US$62.1m. The item's headline also refers to a Philips compatibility declaration, but no details of it were available for this report.

What it means for your team

  • Paediatric label expansions for NorthStar and the Vision-MR Diagnostic Catheter widen the population in which the system can be marketed in the US.
  • Closure of the manufacturing module of the ablation catheter PMA is a procedural step; the remaining PMA review and any decision are not covered in the available information.
  • Completed 510(k) submissions for the NavTrac introducers put those products under FDA review; clearance has not been reported.
  • Revenue of US$188k in the quarter indicates the US commercial launch is at a very early stage.

Company's press release (SEC filing): Imricor Medical Systems, Inc. ↗

Article written by VigiEye from the official source (Imricor Medical Systems, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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