JLK Applies for FDA Approval of 'Stroke Diagnosis AI Solution'

Medical AI specialist company JLK announced on the 27th that it completed the approval application for its stroke diagnosis AI solution JLK-LVO to the U.S. Food and Drug Administration (FDA) on the 24th (Korean time).

JLK's stroke diagnosis AI solution JLK-LVO
Photo by JLK

JLK-LVO is an AI-based solution that rapidly detects large vessel occlusion (LVO) through vascular angiography computed tomography (CT) images. Ischemic stroke occurs when an occlusion blocks cerebral blood vessels, reducing blood flow to the brain, causing brain tissue to malfunction or become damaged.

JLK aims to increase sales and profits by entering the U.S. market after FDA approval. In particular, since the insurance reimbursement for AI solutions detecting LVO in the U.S. is about $1,040 (approximately 1.42 million KRW) per case, there is an expectation for further sales growth.

Kim Dong-min, CEO of JLK, said, “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 ultimately play an important role in improving patient survival rates and quality of life.”