Noul Co., Ltd. (CEO Chan-Yang Lim, hereinafter referred to as Noul) announced that its MyLab platform and two AI-based software medical devices and cartridges have received medical device approval from the Thailand Food and Drug Administration (TFDA). This approval allows Noul to fully commercialize its flagship products in Thailand, the largest medical device market in ASEAN.
Noul's products approved by the Thai Ministry of Food and Drug Safety include the miLab™ Platform, the AI-based blood analysis solution miLab™ Cartridge BCM, and the AI-based malaria diagnostic solution miLab™ Cartridge MAL. Noul has been receiving approvals in key ASEAN countries, including Indonesia, Malaysia, the Philippines, and Vietnam, since 2024, and its entry into the Thai market has laid the foundation for expanding sales across all five ASEAN countries.
ASEAN countries are experiencing a steady increase in demand for healthcare services due to factors such as aging populations, urbanization, and the rise of single-person households. In particular, Thailand's medical device market is expected to grow from approximately US$1.81 billion in 2019 to approximately US$3.38 billion by 2027. The market is continuing to grow, driven by factors such as an aging population, government policies to foster the healthcare industry, and the expansion of private hospitals.
The miLab™ Cartridge BCM is an innovative product that can replace the peripheral blood smear (PBS) test, which is performed approximately 680 million times annually. It is a first-in-class solution suitable for both large and small diagnostic laboratories. The miLab™ Cartridge MAL was described as "the most advanced digital microscopy platform" in a Unitaid report and is highly regarded internationally as a point-of-care malaria diagnostic technology.
Noul CEO Lim Chan-yang stated, "With the approval of our blood analysis and malaria products in Thailand, the largest medical device market in ASEAN, we can now sell our key products in all five ASEAN countries. With this Thai certification as a catalyst, we plan to expand our business in earnest into the ASEAN market, following our previous success in Europe and the UK. We are currently in detailed business discussions with several countries, and we anticipate positive results."
Meanwhile, Noul's AI-based malaria diagnostic solution, miLab™ Cartridge MAL, recently demonstrated unparalleled performance, achieving 100% AI accuracy in a joint study with Labcorp, the largest diagnostic lab chain in the US. The AI-based blood analysis solution, miLab™ Cartridge BCM, has signed supply contracts in Italy and Germany, and will be fully launched in the European market starting in 2024. As a fully automated, compact blood testing solution, it is attracting attention as a cost-effective product that improves blood testing workflows.
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