Gambro BCT Inc first automated whole blood processing system received clearence from FDA

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Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced that it received FDA clearance for the commercial sale of Atreus® Whole Blood Processing system in the United States.

Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced that it received FDA clearance for the commercial sale of Atreus® Whole Blood Processing system in the United States.

The Atreus system includes both automation and informatics capabilities. The Atreus device automates the manufacturing process of a unit of whole blood. Replacing balances, centrifuges, expressers, sealers, and scales, the Atreus system significantly reduces variability from the manufacturing process.

Michael Seely Senior Vice President and General Manager said, Our system is truly revolutionizing the blood banking industry by simplifying whole blood processes through automation and informatics.  The combination of automation and informatics provides consistently high product quality, standardizes business processes and allows for scalability and flexibility

The Atreus system includes an integrated, user-friendly web application that configures the Atreus device(s), defines workflow, automates data capture, generates data-rich managerial reports and centralizes documentation for enhanced regulatory control.

David B. Perez President and Chief Executive Officer said, We are dedicated to developing and commercializing technology innovations that serve our customers in the blood banking and transfusion medicine industry.  This 510(k) clearance reflects our commitment to investing in research and development focused on enhancing blood quality, safety, supply and efficiency