Noul secures FDA registration for AI-based cervical cancer diagnostic cartridge

Korean artificial intelligence (AI)-based blood and cancer diagnostics company Noul Inc. said it has completed the U.S. FDA device listing for two key components of its cervical cancer diagnostic solution miLab CER -- the miLab Cartridge CER and SafeFix CER wash solution.

Noul’s miLab CER is an AI-driven cervical cancer diagnostic solution that automates cytopathology testing, integrating sample preprocessing, imaging, and AI analysis. The system was recognized in a 2024 WHO–UNITAID report as one of the world’s top three products for cervical cancer diagnostics, alongside Roche and Hologic.

Cervical cancer remains a major public health concern in the U.S., where five-year survival rates exceed 90 percent with early detection but fall below 20 percent for late-stage diagnoses.

Screening rates are particularly low among uninsured and low-income women, with participation more than 20 percent below the national average. African American women also face higher risks, with incidence rates 60 percent higher and mortality more than double those of white women, underscoring persistent disparities by race, income, and geography.

The device listing marks the company’s fulfillment of the minimum regulatory requirement to sell and distribute the products in the U.S. market.

With the new listing, Noul has expanded the scope of its miLab platform, which already includes malaria diagnostics and blood analysis cartridges, to establish a foothold for U.S. market entry in cervical cancer diagnostics.

The company is also preparing stepwise FDA 510(k) premarket submissions for disease-specific analysis software that will be integrated into the registered miLab platform, aiming for a smooth regulatory process in the years ahead.

“This registration of the miLab CER product family is an important step for our entry into the U.S. and will strengthen our momentum for global market expansion,” Noul CEO David Lim said. “With upcoming launches in Europe and Latin America, we will begin shipments in markets where we already secured regulatory approvals, such as Qatar, Panama, and the U.K.”

From October, Noul will begin full-scale launch of the miLab CER solution in Europe and Latin America.

Earlier this year, the company secured supply contracts in six Latin American countries, including Panama, as well as in Qatar ahead of launch.

Noul has since added regulatory approvals in Switzerland and Vietnam, laying the groundwork for global expansion. With demand already identified in Europe and Latin America, the company said it will leverage its FDA registration to explore accelerated introduction into the U.S. market.