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FDA Expands Clearance for Bayer’s Medrad MRXperion MR Injection System

FDA Expands Clearance for Bayer’s Medrad MRXperion MR Injection System

The U.S. Food and Drug Administration has granted expanded clearance to Bayer’s Medrad MRXperion magnetic resonance (MR) injection system, enabling its use across a broader range of MRI scanners.

The updated clearance extends the labelled field strength compatibility of the Medrad MRXperion to MRI scanners with magnetic fields of up to 7T (Tesla). The system is used to deliver contrast agents and saline during magnetic resonance imaging procedures, helping improve diagnostic imaging quality.

The clearance also confirms compatibility with Bayer’s Imaging Scanner Interface 2 (ISI2), a hardware–software communication module designed to synchronise interactions between the MR injection system and MRI scanners. The integration is expected to support improved exam coordination and operational efficiency in MRI suites.

GlobalData analysis also indicates that the contrast media injector market is projected to grow at a compound annual growth rate of 7.5%, reaching an estimated value of $2.8bn by 2035, up from $1.36bn in 2025.

05-03-2026