510(k) clearance from the FDA for the Medrad Centargo CT injection system – Bayer

Bayer announced  510(k) clearance from the 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.

“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.”

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 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.