Curetis N.V. (the "Company" and, together with Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today provided an update regarding the ongoing interactive review by the U.S. Food and Drug Administration (FDA) of its 510(k) application for clearance of the Unyvero Platform and Lower Respiratory Tract Infection (LRT) Application Cartridge.
On April 21, 2017, Curetis participated in a Meeting with a team of FDA reviewers, discussing the FDA’s request for additional information communicated to the Company in March 2017. Meeting minutes have been drafted and confirmed by Curetis and FDA as of May 23, 2017.