Noul, an AI-based blood and cancer diagnostics company, said Wednesday that it had received medical device approval for its blood analysis solution, DMLA, with miLab BCM Application (miLab BCM).

Noul's miLab BCM is an in vitro diagnostic automated blood cell analysis device that uses cartridges (blood staining reagents) to smear and fix blood, then stain and analyze blood cells. It measures total white blood cell count, red blood cell count, platelet count, hemoglobin concentration, hematocrit value, and more. It also classifies blood cells by type and identifies immature blood cells.

It also allows healthcare professionals to review results and reclassify blood cells.

According to Noul, miLab BCM is an alternative to peripheral blood smears (PBS), performed more than 680 million times worldwide. Based on its solid-state staining technology, NGSI (next-generation staining and immunostaining), and fully automated image acquisition, miLab BCM can be expanded to diagnose various blood cancers, including leukemia.

In addition, miLab BCM provides digital images of each blood cell, making blood tests that require highly skilled labor more efficient. It is also a miniaturized, fully automated blood analysis device that does not require specialized personnel to maintain, making it highly useful for small—and medium-sized medical institutions.

“With the acquisition of the domestic license for miLab BCM, we will be able to introduce our blood analysis solution in Korea,” Noul’s Chief Business Officer, Kim Tae-hwan, said. ”We expect to enter the domestic market in earnest and accelerate the global approval process, including the U.S. Food and Drug Administration (FDA), and strengthen the reliability of Noul's products in global markets, including the U.S. and Europe.”

Noul has entered the Indonesian blood analysis solutions market by signing an agreement to supply and exclusively distribute miLab BCM in that country. The product has also been approved for the European, ASEAN, and Middle East markets and is in the process of being cleared by the U.S. FDA.