Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System

Bayer AG Receives FDA 510(k) Clearance for MEDRAD Centargo CT Injection System

Germany-based Bayer AG (ETR: BAYN) has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its MEDRAD Centargo CT Injection System. This innovative multi-patient injector is designed to enhance workflow efficiency and integrates seamlessly with Bayer’s existing portfolio of products, particularly in high-volume CT suites.

Global Registration and CE Mark
The MEDRAD Centargo CT Injection System has been registered in 49 countries and regions since obtaining the CE mark in Europe in 2020. This global recognition underscores the product’s compliance with international standards and its readiness for use in a variety of healthcare settings.

Smart Protocol and Personalized Injection Plans
The system features the Smart Protocol intelligent solution assistant, which can develop personalized injection plans based on the parameters of the amplifier device and patient factors. This advanced functionality allows for tailored procedures that cater to individual patient needs, enhancing both the accuracy and efficiency of CT injections.

Operational Efficiency and Precision
As a piston type multi-patient pipeline CT high-pressure injection system, Centargo simplifies the operation process, thereby improving the work efficiency of radiology medical personnel. The system ensures precise injection and diagnosis, which is crucial for the effective execution of CT procedures and the delivery of high-quality patient care.-Fineline Info & Tech

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