Imricor Submits Third US FDA Premarket Approval Module for Vision-MR Ablation System

MT Newswires Live

Jun 11

Imricor Medical Systems (ASX:IMR) has filed the third module of its premarket approval application with the US Food and Drug Administration (FDA), covering non-clinical bench testing for its Vision-MR Ablation Catheter 2.0, RF-5000 Ablation Generator, and irrigation tubing set, according to a Thursday Australian bourse filing.

The submission contains testing data covering product performance, sterile shelf life, packaging integrity, software testing, electrical safety, electromagnetic compatibility, magnetic resonance safety, and usability, per the filing.

The company is streamlining FDA approval via a modular review process while pursuing additional device clearances, with three products already cleared, including NorthStar, Vision-MR Diagnostic Catheter, and Vision-MR Diagnostic Catheter Cable, the filing added.

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