JLK Applies for FDA Approval of Stroke Diagnosis AI Solution... Full-Scale Entry into US Market

Medical AI specialist JLK has officially entered the U.S. market.

Korea's first AI company listed on KOSDAQ, JLK (CEO Dongmin Kim), announced on the 24th that it has completed the FDA approval application for its AI solution JLK-LVO, signaling its full-scale entry into the U.S. market.

The JLK-LVO submitted to the FDA is an AI-based solution that rapidly detects large vessel occlusion (LVO) through vascular angiography CT images.

JLK plans to maximize sales and profits by securing a foothold in the U.S. insurance reimbursement market with final FDA approval. In particular, since the insurance reimbursement for LVO detection AI solutions in the U.S. is set at $1,040 per case (approximately 1.42 million KRW), which is tens of times higher than in Korea, the company expects a quantum leap in sales.

Additionally, considering the long distances between hospitals in the U.S., where rapid stroke diagnosis, procedures, and transfer decisions are even more critical, JLK has perfectly prepared a localization strategy by integrating the solution into its proprietary application Snappy.

JLK CEO Dongmin Kim stated, “The entry of JLK-LVO into the U.S. market will accelerate innovation in early stroke diagnosis and treatment,” adding, “I am confident it will play a crucial role in ultimately improving patient survival rates and quality of life.”

He continued, “We plan to complete FDA applications for five stroke AI solutions within this year,” and added, “We will accelerate sales growth by entering the U.S. medical market, where insurance reimbursements are high.”

Meanwhile, ‘Snappy’ is an application developed by JLK that contains all 11 types of stroke full-cycle solutions and is available on both mobile and PC. It features a dedicated chat function for medical staff as well as video sharing capabilities, greatly enhancing convenience. More details about Snappy can be found on JLK’s official YouTube channel, JLK-TV.