AITRICS acquired Medical Device KGMP certification
May 18, 2020
AITRICS has acquired medical device KGMP certification from the Ministry of Food and Drug Safety for VitalCare, in-hospital sepsis prediction platform.
Obtaining medical device KGMP means that it satisfies the criteria for manufacturing medical devices of excellent quality. VitalCare, a platform that predicts sepsis using EMR information, is a medical device. Certification by the Ministry of Food and Drug Safety for compliance with medical device manufacturing and quality control standards (KGMP) is essential for production and sales. VitalCare has been certified for the 'Bio Phenomenon Measurement Device' product group. Through this, AITRICS has laid the basis for manufacturing and selling VitalCare as a medical device.
Sepsis is a disease that causes a systemic inflammatory response after infection from microbes, which has a high mortality rate to be selected as the leading cause of death globally. Early detection is the best because there is no underlying cure for sepsis. If sepsis treated within 1 hour after onset, the survival rate is 80%, but after 6 hours, it falls to 30%.
The problem is that the diagnosis is knotty because the symptoms are general. To find sepsis, doctors need to determine whether patients have an infection, but the results of the blood test will come out at least two days later.
VitalCare is AITRICS's AI platform that significantly improves patient safety by timely detection and treatment of the risk factors of various environments in hospitals through real-time monitoring of patients' electronic medical records (EMR). It overcomes the limitations of the existing evaluation tool, which was difficult to timely treatment, by providing an accurate prediction of sepsis considering the correlation between variables through advanced AI technology. The solution aims to handle the patients within the golden hour and optimize resource operations in the hospital.
Based on the KGMP certification of medical devices, AITRICS is planning to immediately conduct the prospective-retrospective clinical study through MOUs with top tier hospitals in Korea and intends to focus on entering the domestic medical device market by completing medical device manufacturing permission.
"We were able to obtain KGMP certification as a source of internal members' expertise and confidence in our products. Hopefully, we hope that VitalCare will be commercialized as soon as possible to reduce sepsis mortality in hospitals and contribute to saving one's life. We will continue to make efforts to become the first medical device to predict sepsis based on artificial intelligence in Korea," said Jinkyu Yoo, CEO of AITRICS.