New FDA 510(k) Clearance Expands Bayer’s MEDRAD® MRXperion MR Injection System Support Across Diverse Range of MR Environments

• Clearance reinforces Bayer’s continued commitment to dependable, integrated radiology solutions
• Expanded Tesla compatibility captures low- to high-end field magnetic resonance (MR) systems, now supporting up to and including 7T
• Imaging Scanner Interface 2 synchronizes contrast injection with MR scanning to simplify operator workflow

WHIPPANY, N.J.--(BUSINESS WIRE)--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.

About MRI

MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to 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.

About Radiology at Bayer

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

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer 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. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Forward-Looking Statements

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