Archive: Company News
Company News: Curetis Accelerates 510(k) Submission Preparation for Unyvero LRT in BAL Specimen Based on Positive FDA Feedback
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— S. FDA and Curetis agree on 510(k) requirements for clearing BAL as additional sample type for Unyvero LRT
— S. commercial roll-out gaining traction, with first dozen Unyvero Analyzers placed and first commercial evaluation agreements signed
Curetis N.V. (the “Company” and, together with its subsidiaries, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that following a recent meeting, the U.S. FDA has confirmed the suitability of the 510(k) clearance pathway for Curetis’ Unyvero LRT Application Cartridge specifically optimized for the detection of microbial pathogens in bronchoalveolar lavage (“BAL”) samples. Read more…


