South Korean medical AI firm JLK has received 510(k) clearance from the U.S. Food and Drug Administration for its stroke analysis tool, JLK-CTP. This marks the company’s third FDA approval in 2024, following earlier nods for prostate and large vessel occlusion solutions.
JLK-CTP uses artificial intelligence to analyze brain CT perfusion scans, automatically calculating infarct core and perfusion deficit volumes. The technology aims to expedite surgical decision-making by providing precise stroke damage assessments.
A study published in Frontiers last May suggested JLK-CTP outperformed a competing U.S. product in accuracy and concordance when predicting infarct core volumes.
The FDA green light is expected to support JLK’s expansion into the U.S. and Japanese markets. In Japan, where insurance reimbursement for CT perfusion-based stroke treatment is under consideration, JLK has already submitted approval applications for JLK-CTP and a related MRI-based product.
CEO Kim Dong-min cited the string of FDA approvals as validation of JLK’s solutions. The company plans to pursue additional FDA applications for stroke-related products this year, aiming to leverage its growing portfolio to capture market share in the competitive medical device landscape.
