Archive: Company News
Company News: Curetis’ Unyvero BCU Blood Culture Application Receives Approval from Singapore Health Sciences Authority
— Second market authorization for Unyvero Cartridges this year in Singapore
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that Acumen Research Laboratories Pte. Ltd. (Acumen), its partner for the commercialization of Unyvero in the ASEAN region, earlier today has received approval by the Singapore Health Sciences Authority (HSA) to market the Unyvero BCU Cartridge for bloodstream infections in Singapore.
Company News: Curetis to Hold Investor Conference Call with Webcast on U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge
After having obtained the De Novo clearance by the U.S. FDA for its Unyvero System and the Unyvero LRT Application Cartridge, Curetis N.V. will host a public investor conference call with webcast today, April 4, 2018, at 03:00 pm CEST / 09:00 am EDT.
In this call Curetis will provide an overview on the Unyvero System and LRT Cartridge for the U.S. market, the FDA De Novo clearance decision and the underlying U.S. clinical evaluation data, and the planned U.S. launch and market development activities.
Company News: Curetis Receives U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge
– First ever multiplex MDx test to be granted clearance by the FDA for this indication
– Commercial launch in the U.S. expected this quarter
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, announced today that the Company has been granted a De Novo clearance by the U.S. Food and Drug Administration (FDA) to market the Unyvero System and Lower Respiratory Tract Infection (LRT) Application Cartridge in the U.S.
Company News: Curetis To Attend Key Investor and Scientific Conferences In The Second Quarter 2018
Curetis N.V. (the “Company” and, together with Curetis USA Inc. and Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today announced that the Company is going to attend several industry conferences in the second quarter of 2018.