JLK, a Korean medical artificial intelligence company, said Tuesday it has obtained regulatory approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for its AI analysis solution based on brain susceptibility weighted imaging (SWI) MRI scans.

SWI is an advanced imaging technique that provides highly detailed visualization of small hemorrhages in the brain, such as microbleeds and chronic bleeding.

While the method offers superior resolution and allows physicians to detect very small lesions, the large number of high-resolution images generated during each scan has traditionally made interpretation time-consuming and burdensome for clinicians.

JLK said its SWI-based AI solution addresses these challenges by automatically detecting and quantifying lesions. This not only reduces fatigue and workload for radiologists but also streamlines the diagnostic process, potentially shortening the time required for patients to receive appropriate treatment.

“SWI is especially powerful in detecting subtle bleeding signals inside the brain,” the company explained, noting that until now, physicians had to manually count and record each suspected lesion. The AI tool now allows more accurate and efficient interpretation, enhancing both clinical value and patient outcomes.

The company already holds PMDA approval for its diffusion weighted imaging (DWI)-based stroke diagnosis solution, JLK-DWI. With the addition of SWI approval, JLK said it now has regulatory clearance in Japan to cover a full spectrum of brain MRI diagnostics -- from large ischemic stroke lesions to microhemorrhages.

Including this latest approval, JLK’s total number of PMDA-cleared solutions has reached seven, matching the seven approvals it has previously obtained from the U.S. FDA.

“With PMDA approval for both SWI and DWI solutions, our brain imaging AI technology has proven its robustness in one of the world’s toughest regulatory markets,” JLK CEO Kim Dong-min said. “We will strengthen collaborations with major university hospitals and medical institutions in Japan to expand adoption, while accelerating our entry into the global market.”