Noul Co., Ltd. (CEO Chan-Yang Lim, hereinafter referred to as Noul) announced that it has completed registration for use in the UK market for its MyLab platform and three AI-based software medical devices and cartridges. This expansion expands Noul's European export routes beyond existing EU markets like Germany and France to include key regions in the UK.
In vitro diagnostic medical devices sold in the UK market must be separately registered with the Medicines and Healthcare products Regulatory Agency (MHRA), based on the CE certification obtained for existing sales in the European market. Noul completed MHRA registration for its main products in January 2025.
The products registered with the MHRA this time are Noul's entire main product line, including its miLab™ Platform, AI-based software for blood analysis, cervical cytology, and malaria testing, three cartridges (miLab™ Cartridge BCM, miLab™ Cartridge CER, miLab™ Cartridge MAL), and fixative solution (SafeFix™).
Noul Chief Business Officer Kim Tae-hwan said, “We have completed product registration with the MHRA to accelerate our entry into the European market, including the UK. We have also secured local experts well-versed in the NHS, which accounts for over 90% of the UK market. Noul has recently achieved tangible results with key European customers, such as supplying miLab™ BCM to Limbach Group, Germany’s leading diagnostic lab chain, and to large Italian hospitals and screening centers. With steady demand from major customers, including large lab chains and small and medium-sized hospitals in Europe, this certification will serve as a catalyst for the full-scale market expansion of Noul’s AI-based blood testing solution and WHO-UNITAID-accredited cervical cytology solution.”
The UK in vitro diagnostic (IVD) market is projected to grow from approximately $3.96 billion in 2024 to approximately $5.7 billion in 2029, at a compound annual growth rate (CAGR) of 7.59%. The growth of the UK IVD market is driven by factors such as the rise in chronic diseases, technological advancements, and changing regulatory environments. Driven by the UK government's proactive push to expand digital healthcare, the digital healthcare market is also experiencing explosive growth, with a compound annual growth rate (CAGR) of 18.62%, projected to grow from approximately $10.9 billion in 2023 to approximately $60.1 billion in 2033.
Meanwhile, Noul's miLab™ BCM is an innovative product that can replace the peripheral blood smear (PBS) test, which is performed over 680 million times worldwide. It is a first-in-class product that covers both large and small diagnostic laboratories. miLab™ CER is an AI-based cervical cytology test (Cytology) product, and in a 2024 WHO-UNITAID report, it was recommended for use alongside products from global diagnostic companies Roche and Hologic.
- See more related articles
You must be logged in to post a comment.