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Roche BenchMark Ultra Plus

Roche has launched its BenchMark Ultra Plus tissue staining system in the EU. The system, a continuation of Roche's BenchMark series, includes hardware, software, and assays for immunohistochemistry and in situ hybridization staining in anatomic pathology labs. The Ultra Plus offers remote monitoring with a connected device, new indicator lights, a retractable work surface, new slide drawers, a new integrated touchscreen, and more environmentally friendly waste segregation and degradation, according to Roche.

The company plans to launch the system in the US and Asia Pacific in September with a worldwide rollout in 2023. The system is a class I medical device in the US, so Class it does not need to be submitted to the US Food and Drug Administration. For the EU, it's a class A medical device under the In Vitro Diagnostic Regulation, which also does not require a regulatory submission.