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Ortho Clinical Diagnostics obtains FDA 510(k) approval for Ortho Vision analyzer

Ortho Clinical Diagnostics has received 510(k) approval from the US Food and Drug Administration (FDA) for its automated Ortho Vision analyzer, developed for transfusion medicine laboratories.


The approval allows commercial sale of Ortho Vision Analyzer for Ortho ID-MTS Column Agglutination technology in the US and Puerto Rico.

Ortho Clinical Diagnostics COO Robert Yates said: "With the launch of the Ortho Vision Analyzer, our goal is to help improve the safety of blood transfusions by reducing the lab’s reliance on manual methods.

"The Ortho Vision Analyzer fits into our broader portfolio of integrated solutions that empower our customers to respond to these growing pressures and help contribute to delivering the best patient care."

Featuring secure monitoring technologies for safety checks and balances, the Ortho Vision Analyzer helps transfusion medicine professionals to track critical steps in the immunohematology testing process.

With the help of Intellicheck technology, the analyzer is said to verify and document diagnostic checks throughout the testing process.

The e-Connectivity technology provides round the clock remote data tracking, which monitors instrument performance while maximizing uptime.

According to the firm, laboratory personnel can also log on anytime and anywhere to collaborate on interpreting results in real time.

The firm already markets a version of the Ortho Vision Analyzer in Europe, Japan, Latin America, Canada and Australia.

Image: Ortho Vision analyzer is an automated analyzer for transfusion medicine laboratories. Photo: courtesy of Marketwired / Ortho Clinical Diagnostics.