Imricor Medical Systems (ASX:IMR) submitted its Vision-MR diagnostic catheter for approval under the US Food and Drug Administration's (FDA) 510(k) premarket notification pathway, according to a Monday Australian bourse filing.
The diagnostic catheter is designed to be used under real-time magnetic resonance imaging (MRI) guidance and is a key component of Imricor's full platform of MRI-compatible electrophysiology devices, per the filing.