SK C&C Obtains MFDS Approval for AI Solution Diagnosing Cerebral Infarction

SK C&C announced on the 22nd that its brain infarct diagnosis artificial intelligence (AI) solution, 'Medical Insight+ Brain Infarct,' has received Class 3 medical device approval from the Ministry of Food and Drug Safety (MFDS).

SK C&C's stroke diagnosis artificial intelligence (AI) solution, 'Medical Insight+ Brain Infarct,' has received Class 3 medical device approval from the Ministry of Food and Drug Safety.
[Photo by SK C&C]

The MFDS classifies medical devices into four categories based on their intended use and the potential risk they pose to the human body. Class 3 medical devices are those with a 'moderate potential risk' and undergo rigorous review including MFDS technical documentation and clinical trials.

SK C&C utilized its proprietary deep learning algorithm to train 'Medical Insight+ Brain Infarct' with diagnostic imaging data from thousands of brain infarct patients. During development, the AI diagnostic accuracy was further validated through verification procedures conducted by neurocranial imaging specialists from Seoul National University Hospital and Ajou University Hospital.

'Medical Insight+ Brain Infarct' analyzes non-contrast brain computed tomography (CT) images within seconds to detect abnormalities. It provides the likelihood of brain infarct on a scale from 0 to 100% and categorizes severity into seven levels to help medical staff make rapid decisions within the golden hour. Abnormal areas are highlighted with heat maps or outlines to assist medical professionals in identifying subtle regions that are easy to overlook.

Choi Cheol, Head of SK C&C DX Convergence Group, stated, "Medical Insight+ Brain Infarct is an innovative digital healthcare solution capable of detecting pre-infarct conditions from non-contrast brain CT images." He added, "With this MFDS approval, we hope SK C&C’s stroke diagnosis AI solution will be effectively utilized as a medical device to assist healthcare professionals in urgent medical situations."