8 July 2026 – Minneapolis, MN, United States – Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR) announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for pediatric use of its NorthStar®, along with its Vision-MR® Diagnostic Catheter.
These clearances expand the use of Imricor’s interventional magnetic resonance (iMR) technology to patients of all ages, including children and young adults. This milestone reflects Imricor’s commitment to advancing iMR-guided technology for patient populations that are often underserved by traditional innovation pathways.
Pediatric patients, particularly those with congenital heart disease, frequently require multiple cardiac catheterization procedures throughout their lives. Traditional approaches rely on ionizing radiation, and exposure can accumulate over time. iMR-guided procedures eliminate procedure-related radiation exposure while providing superior soft tissue visualization, enabling physicians to see both anatomy and catheter position with greater clarity during diagnostic and interventional procedures.
By pursuing pediatric clearance, Imricor has taken an important step that many companies do not, reinforcing its leadership in the field of iMR. Imricor is the only company to develop an MR-native 3D mapping and guidance system designed specifically for use inside the MR environment, advancing patient care through a fundamentally different approach to visualization and navigation.
For interventional cardiologists and hospital teams, NorthStar enhances procedural insight by combining real-time catheter tracking with high-resolution MR soft tissue imaging. For patients and families, this represents access to a radiation-free treatment option that aligns with the long-term needs of children requiring repeat interventions.
In the words of Imricor’s VP of Global Sales, Greg Englehardt:
“Expanding our platform to pediatric patients reflects both a clinical and human commitment. Physicians gain the ability to work with superior soft tissue visualization and real-time catheter guidance, while families gain access to a radiation-free approach for procedures their children may need multiple times. Since receiving FDA approval for NorthStar, we have also seen strong inbound interest from leading pediatric hospitals, and this milestone now allows us to directly engage with these institutions as they look to adopt iMR.”
With these clearances, Imricor continues to lead the advancement of iMR by bringing forward technology designed to transform how procedures are performed for both physicians and patients.
Physicians and hospital leaders interested in bringing iMR to their institution can contact Imricor for more information. Parents and caregivers are encouraged to speak with their physician about radiation-free iMR treatment options.