[Edaily Reporter Kim Seung-kwon] #JLK, a company specializing in medical artificial intelligence (AI), announced on the 17th that it has been selected as the lead research and development institution for the project “Overseas Clinical Trials and Regulatory Approval for AI Software for Stroke Treatment in Compliance with Global Guidelines,” part of the Inter-Ministerial Medical Device R&D Program.

This project is being undertaken to conduct confirmatory clinical trials overseas that comply with the regulatory requirements of the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and to obtain global regulatory approvals.

The project will run through December 2028 and has a total budget of 2.8 billion. JLK will oversee the project as the lead R&D institution, with Dongguk University Ilsan Hospital participating as a co-research and development institution. Additionally, the company plans to conduct overseas clinical trials in collaboration with global medical institutions, including Massachusetts General Hospital and Brigham and Women’s Hospital at Harvard University in the U.S., the National Cardiovascular Center in Japan, and Nippon Medical School.

Through this project, JLK aims to obtain U.S. FDA approval for three new solutions—△JLK-LMVO, △JLK-ASPECTS, and △JLK-ISL—in addition to its seven existing approved solutions. Furthermore, in Japan, the company plans to secure additional clinical evidence to obtain reimbursement for its CT and MR perfusion imaging analysis solutions and proceed with the phased PMDA approval process.

Currently, the United States and Japan are considered among the world’s largest medical AI markets. Particularly in the field of stroke, as the clinical application of AI solutions utilizing image-based quantitative analysis technology expands, securing objective clinical evidence and regulatory approvals is regarded as a key requirement for market entry.

Through this project, JLK plans to: △conduct confirmatory clinical trials that comply with FDA and PMDA regulatory requirements; △establish a system for engaging with global regulatory agencies; △ensure clinical data quality control and statistical validation; △secure clinical validity through publication in international academic journals; and △lay the groundwork for expanding global approvals for follow-up products.

A JLK official stated, “This project is a crucial initiative that will secure clinical evidence for approval by the U.S. FDA and Japan’s PMDA and strengthen our foundation for global commercialization,” adding, “We plan to collaborate with world-class medical institutions to secure data that meets international regulatory standards and accelerate our entry into the global stroke AI market.”