South Korea’s JLK Inc., an AI-based diagnosis solution and platform maker, said on Monday it got 501K approval from the US Food and Drug Administration (FDA) for its AI-based intracerebral hemorrhage (ICH) diagnosis solution JLK-ICH.
JLK-ICH is an AI solution that analyzes CT images of a patient's brain to detect areas of brain hemorrhage.
It received the FDA's 501K without a completion response letter (CRL).
JLK explained that this product will work with its existing JLK-LVO, JLK-CTP, and JLK-PWI to address the entire stroke cycle, from diagnosis to treatment decision.
Write to Jeong Min Nam at peux@hankyung.com
Kim Dong-min, chief executive of JLK South Korea’s JLK Inc., an AI-based stroke care platform maker, will go all out to build its foothold in the US this year, aiming to lift its sales by more than 150-fold to 600 billion won ($454 million) by 2028, its chief executive said.Founded in 201