AITRICS 'VitalCare' Designated as Innovative Medical Device

Kwangjun Kim, CEO of AItrix (Professor of Geriatrics, Severance Hospital)

[Asia Economy Reporter Chunhee Lee] Medical AI technology specialist AITRICS announced on the 26th that its emergency situation prediction solution 'AITRICS-VitalCare (AITRICS-VC)' has been designated as the 27th innovative medical device by the Ministry of Food and Drug Safety.

An innovative medical device is a medical device designated by the MFDS commissioner that significantly improves safety and efficacy compared to existing medical devices or treatments in fields with high technological intensity and rapid innovation. Once designated as an innovative medical device, it can receive various benefits such as priority review of medical devices, special approval exemptions for stepwise reviews, and future government support projects or policy support under the Medical Device Industry Act.

VitalCare is AI software that assists diagnosis by predicting patient condition deterioration. It predicts the risk of death within 6 hours for ICU patients, death within 6 hours for general ward patients, unexpected ICU transfers, cardiac arrest, and sepsis occurrence within 4 hours. VitalCare was designated as an innovative medical device based on the results of three confirmatory clinical trials conducted last July, research papers, and patents. It has been approved by the MFDS in October and is being introduced in domestic hospitals.

VitalCare is the first and only domestic solution to prove predictive performance for sepsis, death, and unexpected ICU transfers in general wards, as well as death prediction performance within the ICU. Accordingly, it is expected that medical staff in general wards and ICUs will be able to predict risk factors and respond in advance before specific emergency situations occur in patients.

AITRICS' emergency situation prediction solution 'AITRICS-VitalCare (AITRICS-VC)' (Photo by AITRICS)

Kim Kwangjun, CEO of AITRICS, said, “Through this designation as an innovative medical device, not only the clinical performance of VitalCare but also our company's AI technology based on biosignals has been proven. Starting with this designation, we will continue R&D next year by participating in various government support and research and development (R&D) support projects.”

AITRICS is currently undergoing a new medical technology evaluation exemption for VitalCare and plans to pursue various certifications to recognize the company's value and technological capabilities, such as innovative medical device software manufacturer and innovative medical device company certifications.

This content was produced with the assistance of AI translation services.