South Korean medical technology firm JLK Inc. secured FDA clearance for its artificial intelligence software that detects brain hemorrhages in CT scans, expanding its portfolio of stroke diagnosis tools.
The company’s JLK-ICH solution received 510(k) clearance from U.S. regulators without requiring additional information, a process that typically indicates a smooth approval pathway. The software is designed to automatically identify areas of bleeding in the brain by analyzing computed tomography images.
JLK plans to integrate this new tool with its existing products, including JLK-LVO for large vessel occlusion detection and JLK-CTP and JLK-PWI for perfusion analysis. The combined suite would offer physicians a more comprehensive approach to stroke assessment and treatment planning.
The approval marks another step in the growing adoption of AI tools in radiology, particularly for time-sensitive conditions like stroke where rapid diagnosis is crucial. However, the real-world performance of such AI systems still needs to be validated through extensive clinical use.
The company did not disclose pricing details or specific rollout plans for the U.S. market.
