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- FDA registration fulfills requirements for U.S. market entry
- Initial shipments to Europe and Latin America to begin with pre-approved countries
YONGIN, South Korea, Sept. 23, 2025 /PRNewswire/ — 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.
Noul’s miLab™ platform with cervical cancer diagnostic cartridges (miLab Cartridge 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.
About Noul Co., Ltd.
“Enabling blood and cancer diagnostics anywhere in the world with AI.”
Founded in December 2015, Noul (376930.KQ) is an on-device AI healthcare company with a mission to explore global challenges that threaten human health and life, discover novel solutions, and realize those possibilities. Noul has commercialized the world’s first AI-powered diagnostic lab, miLab™, through convergence of AI, biotechnology, and compact robotics.
The miLab™ Platform is the only solution that fully automates the microscopic diagnostic process—from sample preparation to AI-based image analysis—delivering lab-grade blood and cancer diagnostics at the point of care. Within 15 minutes, miLab™ produces precise results even in low-resource settings.
In 2022, miLab™ was described in a UNITAID report as “The most advanced digital microscope and fully integrated bench-top platform” for malaria diagnostics. It is now deployed in 28 countries, used by pharmaceutical companies, hospitals, labs, and public health institutions worldwide.
With strong clinical validation and proven performance, Noul is rapidly expanding its market presence, especially in malaria, blood analysis, and cervical cancer diagnostics. The company’s vision is to make a meaningful impact on the lives of 1 billion people worldwide through accessible, innovative diagnostic technologies.
Website: https://noul.com
