Imricor Medical Systems (ASX:IMR) received US Food and Drug Administration (FDA) clearance to expand pediatric use of its NorthStar iMR navigation system and Vision-MR diagnostic catheter, according to a Thursday Australian bourse filing.
The approvals permit both devices to be marketed to patients of all ages, including children and young adults, especially those receiving care at more than 250 children's hospitals across the US, per the filing.
The company said its interventional magnetic resonance imaging approach may be beneficial in pediatric cardiology for congenital heart defects requiring repeated catheterizations, eliminating exposure to ionizing X-ray radiation.