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Ortho Transfusion Medicine Middleware Receives CE Mark

NEW YORK (360Dx) – Ortho Clinical Diagnostics said Wednesday that it has received the CE mark for its Ortho Connect V2.0 middleware, which streamlines laboratory operations and enables lab professionals to manage multiple instruments from a single console.

The firm said that it developed the middleware for its transfusion medicine portfolio to address demands placed on lab managers, whose limited staff have diverse skill sets and need to serve an expanding array of health networks.

The middleware lets users define rules specific to their needs and provides a connection with laboratory information systems in hospitals for the firm's Ortho Vision and Ortho Vision Max immunohematology analyzers, enabling the analyzers to exchange data and simplify processes, Ortho said.

With Ortho Connect V2.0, lab professionals can automate quality-check testing requirements and results validation. They can leverage the middleware to simplify data management, regulatory requirements compliance, and the implementation of other such processes, Ortho said.

"Ortho is focused on diminishing the complexities of immunohematology testing while improving safety, speed, and efficiency throughout the blood bank," Ortho's COO Robert Yates said in a statement. He noted that the middleware brings improved functionality to laboratory information systems that are often relatively rigid and outdated.

Ortho Connect V2.0 is now available for purchase in Europe and other countries that accept the CE mark.

The CE mark comes on the heels of another regulatory clearance for Ortho. In November 2016, it received 510(k) clearance from the US Food and Drug Administration that permits the sale in the US of the Ortho Vision Max analyzer for use in high-volume transfusion medicine laboratories.