JLK , a medical artificial intelligence (AI) company, announced that its AI analysis solution based on brain Susceptibility Weighted Imaging (SWI) has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
SWI is a high-resolution MRI imaging technique that can precisely identify microscopic lesions, such as cerebral microbleeds and chronic hemorrhages, contributing to improved diagnostic accuracy. JLK has developed AI technology that automatically analyzes this imaging data, enabling medical professionals to more quickly and accurately diagnose various conditions, including cerebrovascular disease, traumatic injuries, and degenerative brain diseases.
In particular, SWI imaging, due to its high resolution and three-dimensional nature, generates a large number of images. Previously, manually identifying and recording lesions required considerable time and fatigue for medical staff. JLK's AI solution automates lesion detection and calculations, reducing this burden and increasing diagnostic efficiency, highlighting its clinical utility.
With this approval, JLK has secured its second brain imaging AI solution approval in Japan, following its previously PMDA-approved diffusion-weighted imaging (DWI)-based stroke diagnosis solution (JLK-DWI). With this approval, JLK now has approval in Japan for a wide range of brain imaging AI solutions, from large lesions like acute cerebral infarction to microhemorrhages.
Currently, JLK has received approval for a total of seven AI solutions from the U.S. Food and Drug Administration (FDA), and with this PMDA approval, the number of approved solutions in Japan has also increased to seven.
JLK CEO Kim Dong-min said, “SWI approval is another achievement in passing Japan’s medical device regulations and an opportunity to prove the reliability of our brain imaging AI technology.” He added, “We will strengthen cooperation with major medical institutions in Japan and lay the foundation for expansion into the global market.”
JLK plans to expand the distribution of SWI and DWI-based AI solutions through collaboration with local Japanese distribution partners in the future, and further strengthen its position in the global medical AI market centered on comprehensive brain imaging analysis technology.
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