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

Key Terms

510(k) regulatory

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

magnetic resonance imaging medical

Magnetic resonance imaging (MRI) is a medical scan that uses strong magnets and radio waves to make detailed pictures of the inside of the body without X-rays or surgery. For investors, MRI matters because the machines, software, maintenance, and scan services represent steady capital spending and revenue streams for equipment makers, hospitals and imaging centers; advances or wider adoption can change market size, pricing power and competitive dynamics much like a camera upgrade transforms picture quality and demand.

mri medical

Magnetic resonance imaging (MRI) is a medical scan that uses magnetic fields and radio waves to create detailed pictures of the inside of the body, like a high-resolution camera for tissues and organs. Investors care because MRI drives demand for imaging machines, hospital services, diagnostics and can be central to clinical trial results and regulatory decisions—changes in MRI use or technology can affect revenue, capital spending and reimbursement in healthcare and medical device markets.

• 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

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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Source: Bayer