[Edaily Reporter Park Jung-Soo ] Noul Co., Ltd.(376930), a company specializing in AI-based blood and cancer diagnostics, announced on the 18th that it has obtained a Class II medical device license from Health Canada for the “Malaria Diagnostic Cartridge (miLab MAL Cartridge),” a key component of its AI-based malaria diagnostic solution.
With this approval, Noul Co., Ltd. has laid the groundwork for entering the North American market. The company is currently undergoing the approval process for the miLab platform in Canada and is in the final stages of review. Once platform approval is complete, the product and regulatory foundations for the local commercialization of miLab MAL are expected to be in place.
Discussions with local distribution partners are also underway. To enter the Canadian market, Noul Co., Ltd. is discussing product supply and market strategies with potential distribution partners. As soon as the miLab platform receives approval, the company plans to enter the market by targeting local medical institutions and testing facilities.
“With this approval from Canadian health authorities, we have made significant progress toward entering the North American market,” said Lim Chan-yang, CEO of Noul Co., Ltd. “As the approval process for the miLab platform in Canada is in its final stages and discussions with local distribution partners are taking shape, we will rapidly realize business expansion opportunities in key SUNJIN Co., Ltd. markets.”
Canada requires certification under the “Medical Device Single Audit Program (MDSAP),” in which five countries—including Canada, the United States, and Brazil—participate, as part of its medical device approval process. Noul Co., Ltd. secured MDSAP certification last year. Building on this experience with Canadian regulatory approval, the company plans to accelerate its entry into overseas markets such as Singapore and Central and South America.
Noul Co., Ltd.’s AI-based malaria diagnostic solution, “miLab MAL,” is a product that automates the entire microscopic diagnostic process—from blood sample pretreatment to imaging and AI analysis—using on-device AI and solid-state staining technology. Test results are provided within 15 minutes.