Bayer’s Receives FDA Clearance for MEDRAD® Centargo CT Injection System

November 7, 2024

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WHIPPANY, N.J.--(BUSINESS WIRE)-- Bayer announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD ^® Centargo CT Injection System, an innovative multi-patient injector that drives workflow efficiency with design features that integrate with Bayer's portfolio of products, especially in high-volume CT suites. Bayer's MEDRAD ^® Centargo CT Injection System delivers value for radiology departments as the US faces a shortage of radiology technologists coupled with a rising demand for medical imaging.

"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."

MEDRAD ^® Centargo CT Injection System reduces patient set-up time, streamlines workflows and incorporates innovative technology

• The system is designed to minimize prep time as the multi patient set-up can be completed in under two minutes with the pre-assembled Day Set. The snap-in patient line auto-primes upon insertion and is ready for the next patient in less than 20 seconds.
• Streamlining data entry, the integrated barcode reader provides easy traceability and access to contrast and injection details when combined with Automated Documentation software.
• The innovative contrast injection system incorporates a piston-based technology which enables features such as Dual Flow (simultaneous delivery of contrast and saline) providing more flexibility for the most demanding protocols.

Sunnybrook Health Sciences Centre, Toronto, Canada, was the first hospital in North America to install and integrate Bayer's 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," says 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."

Advanced safety features support healthcare providers in high throughput environments

With the rising demand for imaging, radiology technologists are expected to work faster and more effectively while maintaining the highest safety standards. Bayer's technology advancements and innovative design address these needs while incorporating more automation and workflow efficiencies. The MEDRAD ^® Centargo CT Injection System was designed with two check valves in the patient line to mitigate cross-contamination and inlet and outlet air detection with air removal technology within the day set.

The MEDRAD ^® Centargo CT Injection System enables radiology technologists to focus more on patient care and reduces process and administrative burdens for healthcare providers, specifically in high throughput settings. By integrating with Bayer's portfolio of imaging and workflow solutions, healthcare providers can optimize contrast-usage and enable connectivity to the modality worklist and scanner.

The MEDRAD ^® Centargo CT injection system's innovative and user-friendly functionality was awarded with the Red Dot Design Award 2020. In addition, AMCOR, a leading company in responsible packaging awarded the AmeriStar Award for the Quick Pick & Carry Hospital Box-Style Pouch. The innovative packaging solution sets a new standard in medical device packaging by seamlessly integrating functionality, sustainability, and cost-effectiveness.

For more information about MEDRAD ^® Centargo, visit: www.radiologysolutions.bayer.com.

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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros.

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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 confirm them to future events or developments.

Source: Bayer