With this registration, Noul has fulfilled the minimum regulatory requirements for entry into the U.S. market. Beginning in October, the company will launch commercial shipments of miLab CER in Europe and Latin America, starting with countries where regulatory clearance has already been obtained.

In addition to its existing miLab platform for malaria diagnostics and blood analysis, this FDA device listing provides a foothold for Noul to enter the U.S. market with its cervical cancer portfolio. The company is currently preparing phased FDA 510(k) submissions for disease-specific analysis software to be integrated into the miLab platform.