Medical Device Network

Bayer secures expanded FDA clearances for MRI contrast agent injector

The FDA's expanded clearances broaden the application of Bayer's Medrad MRXperion system across a wider range of MR settings.

Ross Law March 05 2026

The US Food and Drug Administration (FDA) has granted expanded clearance to Bayer’s Medrad MRXperion, broadening the magnetic resonance (MR) injection system’s application across a wider range of MRI scanners.

Used for delivering contrast agents and saline during MRI diagnostic procedures, the FDA clearance expansion updates the labelled field strength compatibility of Medrad MRXperion to support MRI scanners with magnetic fields up to and including 7T (Tesla) range.

The FDA clearance also greenlights the injection system’s compatibility with Bayer’s Imaging Scanner Interface 2 (ISI2). The German company anticipates that the introduction of compatibility with I2I2, a hardware-software communication module for synchronising communication between the injection system and MRI scanner, will streamline MR exam coordination and drive operational efficiency in the MRI suite.

Jill Carbone, vice president and head of radiology North America product and pipeline at Bayer, said: “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.”

Bayer’s Medrad MRXperion is part of the company’s radiology segment, grouped within its pharmaceutical vertical. In 2025, the segment contributed €2.21bn ($2.56bn) to the vertical’s total revenue of €17.8bn, representing year-over-year (YoY) growth of 9%. Meanwhile, Bayer achieved a total 2025 revenue of around €45.6bn.

Contrast agents and contrast media are used to enhance the visibility of blood and perfusion in tissues. GlobalData analysis reveals that the global market for contrast media injectors is growing at a compound annual growth rate (CAGR) of 7.5% and is projected to reach a valuation of $2.8bn in 2035, up from $1.36bn in 2025.

According to a GlobalData market model, Bayer held a 40% share of the US contrast media injector market in 2025, slightly trailing Bracco Imaging, which had a market share of 47.5%. On a global basis, however, Bayer led the market in 2025 with a 41.3% share, outpacing Bracco in second place with a market share of 26.9%.