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Ortho Clinical Diagnostics receives FDA 510(k) clearance for customizable middleware system
Ortho Clinical Diagnostics announced it has received FDA 510(k) clearance for its Ortho Connect V2.0, a comprehensive, integrated and customizable middleware system that centralizes operations and workflow across hospitals and networks, which allows blood banks and their data to be managed through one central terminal.
According to a company press release, Ortho Connect acts as an intermediary between instruments and lab information systems, which allows labs to exchange data, perform data management and complete regulatory process tasks not easily performed alone. It also allows laboratories to consolidate operations and workflow across lab networks, the release noted. Through a single validated connection, Ortho Connect reportedly enables the Ortho Vision and Ortho Vision Max immunohematology analyzers to integrate with a hospital’s laboratory information system to exchange data and simplify processes.
“Ortho is focused on diminishing the complexities of immunohematology testing while improving safety, speed and efficiency throughout the blood bank,” Robert Yates, chief operating officer of Ortho Clinical Diagnostics, said in the release. “Ortho Connect does just that, bringing improved functionality to laboratory information systems that are often relatively rigid and outdated. It’s the perfect complement to our Ortho Vision platform of analyzers.”
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