On Tuesday, artificial intelligence (AI)-based diagnostic company Noul announced it had secured approval for its malaria diagnostic medical device in Canada, accelerating its entry into the North American market.
The company received Class II medical device approval from Health Canada for its malaria diagnostic cartridge, the miLab MAL Cartridge.
This approval establishes a regulatory foundation for Noul to commercialize its AI-based malaria diagnostic solution, miLab MAL, in Canada. The company is currently in the final stages of the approval process for the miLab platform.
Once the platform approval is completed, Noul will have met all product and regulatory requirements for local commercialization of miLab MAL in Canada. The firm is also in talks with potential local distribution partners regarding product supply and market entry strategies.
Noul aims to swiftly enter the market by reducing the time needed to establish its distribution network, targeting local medical institutions and testing facilities.
Canada requires certification under the Medical Device Single Audit Program (MDSAP), which Noul secured last year. The company plans to leverage the regulatory experience gained during the Canadian approval process for future expansions into other international markets.
The miLab MAL product automates the entire microscopy diagnostic process, from pre-processing blood samples to imaging and AI analysis, using on-device AI and solid staining technology. The company claims it can provide test results within 15 minutes, reducing dependence on specialized personnel and testing infrastructure.
Lim Chan-yang, Chief Executive Officer (CEO) of Noul, stated that this approval from Canadian health authorities marks a significant milestone in the entry into the North American market. It’s working to finalize the miLab platform approval and local distribution partnerships to quickly capitalize on business expansion opportunities in key developed markets.
Noul’s AI diagnostic platform, miLab, is an all-in-one solution that integrates the entire microscopy diagnostic process—from sample staining to digital imaging and AI analysis—into a single device.
The platform can deliver test results in an average of 15 minutes. Notably, its cervical cancer diagnostic solution, miLab CER, received recommendations for use alongside products from industry giants Roche and Hologic in a 2024 report by the World Health Organization (WHO) and Unitaid.