Korean medical AI firm JLK has secured its second innovative medical device designation for stroke care, this time for JLK-LVO—a real-time software tool that flags large vessel occlusion (LVO), a major cause of fatal or disabling strokes, using CT angiographic scans.

Built for emergency use, JLK-LVO is designed to help clinicians identify suspected blockages in the brain’s major arteries—blockages that, if left untreated, can cause irreversible brain damage or death. 

The tool follows JLK’s earlier designation for JBS-01K, which classifies stroke subtypes, and pushes the company’s broader AI stroke platform further into clinical markets in Korea and the U.S.

“We’re now focused on global hospital adoption and expanding insurance coverage across our broader stroke portfolio,” JLK CEO Kim Dong-min said in a Friday statement.

The regulatory nod comes as Korea’s new fast-track policy for medtech gains momentum. Rolled out last November, the system allows novel devices like JLK-LVO to reach the market within 80 days of approval, skipping previously required multi-agency reviews. Devices can be used for up to three years as non-reimbursed treatments while undergoing full health technology assessments—giving companies early access to clinical settings and real-world data.

JLK expects the designation to accelerate adoption across stroke centers and emergency departments. According to the company, its stroke platform includes more than a dozen AI-based tools, and bundling them into hospital workflows could open new revenue streams and accelerate international expansion.