JLK gets OK from FDA for ICH diagnosis solution

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