Bayer today announced that the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for expanded capabilities of its MEDRAD® MRXperion Magnetic Resonance (MR) Injection System, a power injector designed to support efficient workflow and consistent contrast delivery across a broad range of MR environments.
This updated clearance expands MRXperion’s labeled field strength compatibility to support magnetic resonance imaging (MRI) scanners with magnetic fields up to and including 7T (Tesla) range, offering radiology departments greater flexibility within diverse MR suite configurations. It also introduces Imaging Scanner Interface 2 (ISI2) capability, which enables communication between the injector and scanner system, helping streamline exam coordination and support operational efficiency.
“MRXperion already has a strong track record of delivering dependable imaging performance across clinical settings, and this clearance reinforces and expands on its established reputation as a flexible solution that supports coordinated, efficient workflows across MR systems,” said Jill Carbone, Vice President and Head of Radiology North America Product & Pipeline at Bayer. “The clearance also exemplifies our continued innovation in MR solutions to consistently meet the needs of today’s imaging providers.”
MR systems are deployed across healthcare settings with differing technical and workflow requirements. MRXperion is engineered to support this full spectrum of use, from routine clinical imaging to advanced research applications. The clearance further enhances Bayer’s integrated MR portfolio spanning contrast media, injection systems, software and workflow solutions.
About MRXperion
MEDRAD® MRXperion is a piston-technology power injector used to deliver contrast agents and saline during contrast-enhanced MRI procedures. The system supports streamlined workflow, point-of-care efficiency and injection data management.