Noul Co., Ltd. (CEO Chan-Yang Lim, hereinafter referred to as Noul) announced on the 27th that it has completed registration for use in the Swiss market for three of its MyLab platform AI-based software medical devices and cartridges. This expansion expands Noul's export routes across Europe, extending beyond the EU and UK to Switzerland.
Noul has completed the registration of its entire miLab product line with the Swiss regulatory authority, Swissmedic, for in vitro diagnostic medical devices sold in the Swiss market under Swiss IVD regulations, and has received official distribution approval. The registered products include Noul's entire core product line, including the miLab™ Platform, AI-based software for cervical cytology, blood analysis, and malaria testing, three cartridges (miLab™ Cartridge CER, miLab™ Cartridge BCM, miLab™ Cartridge MAL), and a fixative solution (SafeFix™).
Noul CEO Chan-Yang Lim stated, "Switzerland is the location of Noul's European subsidiary and serves as a key gateway for entering the European market. It is a crucial market for strengthening access to both private and public markets, building on close collaboration with global pharmaceutical companies like Novartis and Merck, as well as international organizations like the WHO. Noul's AI-based cervical cancer screening product, miLab™ Cartridge CER, has received a recommendation for use in the WHO-UNITAID report. Based on this sales registration, we anticipate that discussions on various partnerships with global pharmaceutical companies and lab chains will begin in earnest, securing export momentum."
Switzerland's in vitro diagnostics (IVD) market is estimated to be worth approximately USD 830 million by 2025 and is projected to grow at an average annual rate of 3.14%, reaching approximately USD 940 million by 2029, driven by technological innovation and an aging population. Switzerland's per capita healthcare spending ranks first in Europe (as of 2021) in terms of IVD spending, and this economic strength serves as a stable foundation for investment in the IVD sector. The Swiss government is pursuing various policies to drive the growth of digital healthcare and the IVD market, including the DigiSanté program, which promotes the digitalization of healthcare, and the establishment of a personalized healthcare infrastructure (Swiss Personalized Health Network).
The miLab™ CER, registered with the Swiss Medicines Agency, is an AI-based cervical cytology product. It is a technology recommended for use in the 2024 WHO-UNITAID report, along with global diagnostic companies Roche and Hologic, as one of the top 3 global products. The AI-based blood analysis product miLab™ BCM is an innovative product that can replace the peripheral blood smear test (PBS), which is performed more than 680 million times worldwide, and is a first-in-class product that covers both large and small diagnostic laboratories. miLab™ MAL is introduced as the 'most advanced digital microscope platform' in the 2022 official report of the International Pharmaceutical Purchasing Organization (Unitaid), and is attracting attention as the most advanced point-of-care blood diagnostic product in the international community.
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