Noul Co., Ltd. (CEO: David Lim), a medical AI company specializing in blood and cancer diagnostics, announced that FDA registration has been completed for its cervical cancer diagnostic cartridge miLab™ Cartridge CER and clearing agent SafeFix™ CER, both core components of the company's cervical cancer diagnostic solution miLab™ CER.

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.

CEO David Lim stated "The registration of our miLab CER product line marks an important milestone for entering the U.S. market and a catalyst for our global expansion." He added, "In parallel with the upcoming launches in Europe and Latin America, shipments will begin this month to countries including Qatar, Panama, and the UK, where regulatory approvals are already in place."

Cervical cancer survival rates highlight the critical need for early detection: in the U.S., the five-year survival rate exceeds 90% when diagnosed early but drops below 20% at late stages.Screening disparities remain stark, with uninsured and low-income women participating at rates more than 20% lower than average, and African American women facing a 60% higher incidence and more than double the mortality rate compared to white women.

Earlier this year, Noul secured global supply agreements in six Latin American countries, including Panama, as well as Qatar, prior to launch. The company has since obtained registration in Switzerland and regulatory clearance in Vietnam, building momentum for broader international expansion. With proven demand in Europe and Latin America, Noul now aims to accelerate adoption in the U.S. market.

Noul's miLab CER automates cervical cytology with an integrated AI-powered system that performs sample preparation, imaging, and analysis. The product was named one of the three recommended technologies for cervical cancer triage — alongside Roche and Hologic — in the 2024 WHO–Unitaid report.