FDA Grants 510(k) Clearance to Bayer’s MEDRAD MRXperion MR Injection System

Bayer has earned U.S. Food and Drug Administration (FDA) 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 and 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.

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.

MRI is a non-invasive, radiation-free imaging method that provides detailed body images, helping identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases.

Bayer’s Radiology business is considered a world leader among medical imaging solutions providers. The business transforms insight into technology and services to provide radiology solutions to help its customers enhance patient care. Its radiology portfolio features contrast agents and devices for precise dose administration across modalities, equipment service, informatics, and connected solution offerings.

Bayer is a global enterprise with core competencies in healthcare and nutrition. The company is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. In fiscal 2024, the Group employed around 93,000 people and generated €46.6 billion euros in sales. R&D expenses amounted to €6.2 billion.