Noul's miLab registered FDA's Class I

South Korea's Noul Co., an in-vitro diagnostics maker and artificial intelligence (AI)-based blood and cancer diagnostic platforms company, said on Thursday it received the registration of four medical devices as Class I products with the US Food and Drug Administration (FDA).

Through this registration, Noul has met the legal requirements for the distribution and use of its products in the US.

The company is progressing through the FDA approval process for each solution step by step.

The registered products include Noul’s "miLab Platform," an automated device equipped with solid staining and imaging technologies, two diagnostic cartridges for malaria and blood analysis, and a fixation solution (SafeFix).

The US in-vitro diagnostic market is expected to grow at an annual rate of 7.7%, from $33.9 billion in 2023 to $56.9 billion by 2030.

Write to Jeong Min Nam at peux@hankyung.com