Imricor books $188k in first US sales of MRI-guided heart-procedure platform

Imricor Medical Systems has turned a regulatory milestone into its first American revenue: US$188k in the quarter ended 30 September 2026, according to a report dated 13 November. The sum is small, and it signals a commercial rollout that has only just begun.

The buyers so far are two paediatric centres, Rady Children's in San Diego and Children's Medical Center Dallas. They purchased the NorthStar iMR system, which supports cardiac catheter procedures performed under MRI guidance. The US Food and Drug Administration has widened the labelling for both NorthStar and the Vision-MR Diagnostic Catheter to cover paediatric use, though the summary available to us gave no further detail on the clearances.

The larger prize sits in the ablation pipeline. The FDA has accepted and closed the manufacturing module of Imricor's premarket approval (PMA) application for the Vision-MR Ablation Catheter. Context: PMA is the agency's most demanding pathway for high-risk devices and is often filed in modules. Closing one module is a procedural step, and the information available does not describe the remaining review or any timetable for a decision.

Imricor also said it had completed 510(k) submissions for its NavTrac introducers. A 510(k) rests on showing substantial equivalence to a device already legally marketed. No clearance has been reported. The company ended the quarter with US$62.1m in cash. The original headline mentioned a Philips compatibility declaration, but we have no details on it and do not characterise it here.