FDA OKs Bayer’s MEDRAD Centargo CT Injection System

Bayer has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its MEDRAD Centargo CT injection system, a multi-patient injector with design features that integrate with Bayer’s product portfolio.

The system was designed to minimize prep time, because the multi-patient setup can be finished in under two minutes with the pre-assembled day set, according to Bayer. A snap-in patient line auto-primes upon insertion and is ready for the next patient in under 20 seconds. An integrated barcode reader also can be combined with automated documentation software for easier traceability and access to contrast and injection details.

The contrast injection system uses piston-based technology, enabling features like Dual Flow (simultaneous delivery of contrast and saline) for more flexibility in demanding protocols.

“Since its launch in 2020, Centargo has served approximately seven million patients across 49 markets world-wide. The FDA clearance further demonstrates our nearly 40 years of CT innovation and commitment to delivering effective technologies to improve diagnostic imaging for patients,” said Sven Schmidt, Head of Region Americas Radiology at Bayer. “We know radiologists today are facing a continuously increasing workload, and the automation, integration and mobility of the MEDRAD Centargo CT Injection System helps radiology staff do more with less, allowing them more time to focus on their patients.”

The MEDRAD Centargo CT injection system features two check valves in the patient line. This mitigates cross-contamination and inlet and outlet air detection with air removal tech in the day set. Bayer said providers can optimize contrast usage and enable connectivity to the modality worklist and scanner by integrating with its portfolio of imaging and workflow solutions.

Sunnybrook Health Sciences Centre, Toronto, Canada, was the first hospital in North America to install and integrate the MEDRAD Centargo CT Injection System in both acute care and outpatient settings.

“We’ve found the ease of using the Centargo injection system is having a real impact on our technologists’ ability to do their work quickly and with less worry,” said Mike Minoo, Manager, CT and Interventional Radiology at Sunnybrook. “For example, because I am spending less time preparing the injector and its components, I have more time to spend with the patient, increasing their comfort level and understanding of the procedure. The quality of this interaction provides a better overall experience for both myself as a clinician and the patient.”