JLK, Inc., a medical artificial intelligence (AI) solution specialist company, announced on the 27th that its AI-based MRI FLAIR imaging solution (JLK-FLAIR) has obtained approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare.
JLK-FLAIR is an AI-based solution that analyzes and visualizes high signal intensity areas in MRI FLAIR (Fluid-Attenuated Inversion Recovery) images and measures the volume of these areas.
MRI FLAIR images are used not only to evaluate the appropriateness of treatment for acute ischemic stroke patients but also for quantitative analysis of white matter hyperintensities (WMH), which helps predict cognitive decline and dementia risk.
Japan is one of the fastest-aging countries in the world, making stroke and vascular disease management a national priority. However, the shortage of specialists in neurology, neurosurgery, and radiology within Japan has caused difficulties in precise brain disease analysis and diagnosis.
JLK-FLAIR is an innovative solution that can address these issues. Through AI-based analysis, it improves the standard clinical pathway (CP) for medical professionals and ultimately contributes to patient treatment. In particular, it is expected to enable high-quality image analysis support even in regional hospitals and small to medium-sized medical institutions.
JLK has already obtained approvals for JLK-CTP, JLK-PWI, and JLK-NCCT in Japan, and with this fourth approval for JLK-FLAIR, the company plans to strengthen collaboration with medical institutions in Japan and expand the adoption of AI-based stroke diagnostic solutions.
Industry experts expect that JLK's successive approvals in Japan will change the paradigm of the Japanese stroke AI diagnostic market. They anticipate that AI adoption will enable rapid evaluation of treatment appropriateness for acute stroke patients and support prediction of cognitive decline and vascular dementia risk in chronic patients, contributing to preventive treatment and long-term management.
The company is reportedly aiming to quickly capture the market by capitalizing on the absence of prominent stroke medical AI companies in Japan. Their strategy includes maximizing the utilization of JLK-FLAIR through clinical research collaborations with Japanese hospitals and insurance coverage.
JLK CEO Dongmin Kim stated, “JLK is commercializing its business in Japan through a subscription model for package-type solutions,” adding, “In the Japanese market, package solution sales offer higher profitability relative to maintenance costs compared to individual sales, enabling faster monetization.”
He emphasized, “Compared to single product sales, supplying in a package form maintains the same maintenance costs but increases profit margins without additional expenses. As more solution approvals are obtained, the revenue structure will improve, contributing to increased sales in Japan.”
Meanwhile, according to data published on international medical information portals, Japan’s medical AI market was approximately $1.1 billion (about 1.6 trillion KRW) in 2022 and is expected to grow to $8.9 billion (about 13 trillion KRW) by 2030.
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