• 11 Nov 2024
• Admin
• News Article

US FDA Grants 510(k) Clearance to Bayer’s MEDRAD Centargo CT Injection System

Overview

Bayer, a global enterprise with core competencies in the life science fields of health care and nutrition, announced 510(k) clearance from the US 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. Following CE approval in 2020, the product has already been launched in 49 markets to date, and can now deliver value for radiology departments in the US which is facing a shortage of radiology technologists coupled with a rising demand for medical imaging.

Statement from Bayer

• “Since its launch in 2020, Centargo has served approximately seven million patients across 49 markets worldwide. 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 

• The MEDRAD Centargo CT Injection System enables radiology technologists to focus more on patient care and alleviates 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 system is designed to minimize prep time as the daily 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.

Rising Demand & Technology Advancements

• 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 prevent cross-contamination.

MEDRAD Centargo CT Injection System

• The MEDRAD Centargo CT Injection System is CE certified. Its innovative and user-friendly functionality has been 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.

Bayer for Oncology

• As a true life-science company with a heritage of over 100 years in radiology, Bayer is committed to providing excellence – from innovative products to high-quality services – to support efficient and optimized patient care. 
• Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-ray, and magnetic resonance imaging (MRI), along with devices for their precise administration, informatics solutions, and a medical imaging platform delivering access to applications, including those enabled by AI. 
• Bayer’s radiology products generated about €2bn sales in 2023. Bayer is highly committed to research and development, which includes leveraging AI and driving innovation in medical imaging.

About the Company: 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.