JLK, a South Korean medical AI company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its AI stroke solution, JLK-LVO. This marks the first FDA clearance for JLK's stroke solutions and paves the way for expedited approvals of its other products.
JLK-LVO: AI for Rapid Stroke Detection
JLK-LVO is designed to analyze CT cerebrovascular images and rapidly detect large vessel occlusion (LVO), a critical type of stroke caused by arterial blockage in the brain. The AI-driven image analysis results are transmitted via a mobile app, potentially reducing the time to treatment, which is crucial for improving patient outcomes. According to JLK, American competitors have an insurance reimbursement rate of $1,040 per session for LVO products, and JLK intends to aggressively pursue the U.S. insurance reimbursement market to maximize revenue and profit.
Expansion of Stroke Solution Portfolio
In August, JLK completed the FDA application process for two additional stroke solutions, JLK-CTP and JLK-PWI. The company plans to complete applications for a total of six solutions by the end of the year and aims to secure FDA approval for 2-3 more stroke solutions within the same timeframe. JLK's Snappy, a mobile medical app, allows users to view results from all solutions on mobile devices and PCs, enabling real-time sharing of stroke-related clinical and imaging information.
Leadership Perspective
JLK CEO Kim Dong-min stated that the FDA approval validates the effectiveness of JLK's internally developed FDA regulatory system. He added that the company will diligently pursue its planned FDA applications and accelerate its entry into the global market, starting with the U.S., to help more patients through the rapid regulatory approval and commercialization of its stroke solutions.
