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FDA clears software for immunohematology labs


 

Photo by Darren Baker

Worker in a lab

The US Food and Drug Administration (FDA) has granted 510(k) clearance for ORTHO CONNECT V2.0, a software system developed by Ortho Clinical Diagnostics.

ORTHO CONNECT V2.0 is middleware designed to keep large quantities of data accessible and consistent across multiple instruments and laboratory systems.

ORTHO CONNECT V2.0 works with other products Ortho Clinical Diagnostics has developed for immunohematology labs.

The software is now available for purchase in the US.

According to Ortho Clinical Diagnostics, ORTHO CONNECT V2.0 is comprehensive, integrated, and customizable middleware (software that acts as a bridge between an operating system or database and application).

ORTHO CONNECT V2.0 centralizes laboratory operations and workflow across hospitals and networks, allowing blood banks and their data to be managed through one central terminal. The software can link all Ortho Clinical Diagnostics instruments to lab information systems through a single interface.

Acting as an intermediary between instruments and lab information systems, ORTHO CONNECT V2.0 allows labs to exchange data, perform data management, and complete regulatory process tasks that are not easily performed alone. All test results on connected analyzers can be viewed and verified no matter the location.

ORTHO CONNECT V2.0 enables the ORTHO VISION® and ORTHO VISION® Max immunohematology analyzers, which test blood for transfusion compatibility, to integrate with a hospital’s laboratory information systems through a single validated connection to exchange data and simplify processes.

“Ortho [Clinical Diagnostics] is focused on diminishing the complexities of immunohematology testing while improving safety, speed, and efficiency throughout the blood bank,” said Robert Yates, the company’s chief operating officer.

“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does just that, bringing improved functionality to laboratory information systems that are often relatively rigid and outdated.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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