JLK, Non-Contrast CT Stroke AI Solution Obtains Japan PMDA Approval

Medical AI specialist JLK announced on the 17th that it has obtained approval from Japan's Pharmaceuticals and Medical Devices Agency (PMDA), under the Ministry of Health, Labour and Welfare, for its non-contrast CT stroke AI solution. With this approval, JLK plans to accelerate its market dominance by offering a stroke AI solution package optimized for the Japanese healthcare market.

JLK's non-contrast CT stroke AI solution is a powerful tool that integrates AI functions to assist in diagnosing cerebral hemorrhage and cerebral infarction based on non-contrast CT images. Non-contrast CT is the first imaging performed when stroke patients arrive at the emergency room, making rapid and accurate analysis critical.

The solution is characterized by its ability to detect high-density and low-density areas in the captured non-contrast CT images and calculate the volume of these regions. By combining the strengths of existing solutions, it supports more precise stroke diagnosis and significantly reduces the burden on medical staff in emergency settings where swift diagnosis is essential.

The company expects that applying this solution alongside previously PMDA-approved products such as 'JLK-CTP' and 'JLK-PWI' will revolutionize the stroke diagnosis workflow within the Japanese medical market.

While the solution boasts strong performance when used independently, its combination with other products can support more accurate and faster clinical decision-making, increasing its utility in hospitals and medical institutions across Japan.

Japan is the fastest-aging country in the world, with a high incidence of stroke, making rapid diagnosis and treatment crucial. The number of stroke patients in Japan is increasing annually, and the adoption of AI-based solutions to improve the efficiency of acute phase treatment is rapidly expanding. Consequently, there is growing interest in AI solutions that ensure accuracy and reliability within the Japanese medical community, making JLK's approval highly significant in the market.

JLK plans to fully enter the Japanese market with its non-contrast CT stroke AI solution and expedite PMDA approval applications and acquisitions for remaining stroke-related AI solutions to dominate the Japanese stroke AI market. Through this, the company aims to build a broader product portfolio in the Japanese healthcare market and provide customized solutions to customers.

Additionally, to expand market share in Japan, JLK will actively pursue dealership contracts, significantly increase participation in major Japanese medical exhibitions and conferences, and strengthen marketing activities. The company also plans to actively increase collaborations with hospitals and medical institutions in Japan and widely promote the excellence of its AI-based stroke solutions.

A JLK representative stated, “With the approval of the non-contrast CT stroke AI solution, we will further strengthen our competitiveness in the Japanese medical AI market. We will create a new paradigm in stroke diagnosis by expanding collaborations with Japanese medical institutions alongside additional AI solution approvals.”

With this approval, JLK is expected to solidify its leading position in the Japanese medical AI market and plans to further enhance its competitiveness in the global market through continuous research and development and technological advancement.