Archive: Company News
Company News: Curetis Expects Near-Term FDA Decision on De Novo Request

– Review of the Unyvero System and Lower Respiratory Tract (LRT) Cartridge is nearing completion
– U.S. commercial team and operational infrastructure in place
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today provided a status update on the FDA De Novo filing for the Company’s Unyvero System and LRT Cartridge for the diagnosis of lower respiratory tract infections.


