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FDA Grants Clearance for Ortho Blood Bank Middleware

NEW YORK (360Dx) – Ortho Clinical Diagnostics said today that the US Food and Drug Administration has granted clearance for Ortho Connect V2.0, the firm's integrated and customizable middleware system that centralizes laboratory operations and workflow across hospitals and networks and allows blood banks to manage their data through one central terminal.

The system, now available for purchase in the US, enables the firm's Ortho Vision and Ortho Vision Max immunohematology analyzers, which test blood for transfusion compatibility, to integrate with hospitals' laboratory information systems through a single validated connection and enable exchanging data and simplifying processes.

Robert Yates, Ortho's chief operating officer, said in a statement that the firm is "focused on diminishing the complexities of immunohematology testing while improving safety, speed, and efficiency throughout the blood bank." He said that Ortho Connect does that by bringing improved functionality to laboratory information systems "that are often relatively rigid and outdated."

Ortho Connect, an intermediary between instruments and lab information systems, allows labs to exchange data, perform data management, and complete regulatory process tasks that are not easily performed alone, Ortho said. With it, all test results on connected analyzers can be viewed, verified, and made to interact regardless of the location, and data management and testing process are simplified through lab network connectivity, the firm added.