SK C&C announced on June 18 that 'Brain Bleeding Image Reading AI Model' has obtained a certificate that meets the quality control standards (GMP) of medical device manufacturing.
Good Manufacturing Practice (GMP) is a guarantee system to verify the safety and validity of medical devices produced by medical device manufacturers and ensure that they can be produced consistently with the quality appropriate for their intended use.
The Ministry of Food and Drug Safety controls the necessary management standards throughout the entire process from purchasing raw materials for medical device manufacturing to manufacturing and shipping.
After obtaining GMP certification, SK C&C submitted its clinical trial plan (IND) to the Ministry of Food and Drug Safety for review.
Following the Ajou University Medical Center for the first time, SK C&C developed an AI model that uses CT images from Seoul National University Hospital for the second time. In learning the model, SK C&C Vision AI image segmentation technology and 80,000 brain CT images and reading data were used.
The 'Brain Bleeding Image Reading AI Model' provides reading information at the level of a radiologist within seconds. As cerebral hemorrhage is an emergency disease that must be treated within golden time, rapid and accurate image reading is important.
It is expected to help early diagnosis and treatment of emergency cerebral hemorrhage patients who are in a hurry.
"Artificial intelligence-based image reading models can be expanded to brain nerve diseases such as cerebral infarction and brain tumors as well as cerebral hemorrhage," said Yoon Dong-joon, head of SK C&C's Healthcare Group. "We will work with domestic and foreign medical institutions to contribute to the development of domestic medical AI services focusing on brain diseases."
