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FDA clears Ortho Vision Max blood analyzer
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Ortho Clinical Diagnostics received FDA clearance for Ortho Vision Max, a fully automated blood analyzer intended for use in high-volume transfusion medicine laboratories.
The instrument is now commercially available in the United States. It also is available in Japan and Europe.
Ortho Vision Max has been developed for laboratories that conduct more than 50 types and screens per day. It also is designed to support complex immunohematology testing, including reflex tests, selected cell antibody identification and serial dilutions for titration studies, according to an Ortho Clinical Diagnostics–issued press release.
“Labs are continuously pushed to accomplish more with fewer resources — including staff — and Ortho can now ease those pressures in labs of every size and makeup,” Robert Yates, chief operating officer of Ortho Clinical Diagnostics, said in the press release. “Whether they perform 15 tests per day or 150, the Ortho Vision platform helps labs better manage their contribution to the overall critical-care path.”
The system is designed to be responsive and flexible enough to allow transfusion medicine departments to process routine samples and STAT orders as they are received.
“Transfusion medicine departments are now focused not only on testing, but on connecting their work to patient outcomes,” Heidi Casaletto, head of transfusion medicine at Ortho Clinical Diagnostics, said in the press release. “A comprehensive portfolio of products operating on a single platform means engaging with one user interface, ordering one set of consumables, one set of process and procedures and streamlining training for everyone in the department. It also means more rapid delivery of actionable results that would increase the efficiency of patient diagnosis and a recommended treatment plan.”