JLK, Korea’s first publicly listed medical AI company, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its AI-based stroke detection solution, JLK-LVO. This approval, a first for JLK’s suite of stroke solutions, enables the company to accelerate further regulatory processes for additional products.
JLK-LVO is designed to analyze CT cerebrovascular images and swiftly identify large vessel occlusion (LVO), a severe stroke caused by arterial blockages in the brain. The AI-generated results, viewable via a mobile app, can help reduce time to treatment—a critical factor in improving stroke patient outcomes. With LVO solutions from competitors in the US currently reimbursed at $1,040 per session, JLK aims to tap into the US insurance market to drive revenue growth.
JLK is also pursuing FDA approval for two more stroke solutions, JLK-CTP and JLK-PWI, with plans to submit applications for six products by year-end. The company’s mobile app, Snappy, allows real-time sharing of clinical and imaging data across devices, further enhancing the platform’s utility in stroke care. The FDA clearance positions JLK for rapid expansion into the US and global markets, as it continues to build out its portfolio of AI-driven medical solutions.
