South Korean medical technology firm JLK secured US Food and Drug Administration clearance for its artificial intelligence-based stroke diagnosis solution, marking its fourth regulatory win in 2024.
The latest approval covers JLK-PWI, software that analyzes brain MRI perfusion images to identify infarction areas. In a study at Chonnam National University Hospital, the tool achieved a 98.1% detection rate for stroke lesions, compared with 38.6% for competing technology from Rapid AI.
The clearance follows FDA approvals earlier this year for JLK’s prostate cancer diagnosis system in June, stroke vessel detection tool in September, and CT-based stroke assessment solution in October.
JLK plans to seek FDA clearance for three more stroke-focused products this year as it targets the US healthcare AI market, valued at approximately 21 trillion won ($15.9 billion) in 2022. The company raised 49 billion won ($37 million) through a rights offering in October to fund its US expansion.
President Kim Dong-min said the company aims to establish itself as a comprehensive stroke solution provider covering both CT and MRI technologies in the US market, where reimbursement rates for AI medical devices exceed those in South Korea.
