AITRICS wins Malaysian approval for AI patient deterioration solution

AITRICS, a Korean medical AI company, said Tuesday that it has received medical device approval from Medical Device Authority (MDA) for its AI-powered patient deterioration prediction solution, AITRICS-VC (VitalCare).

VitalCare is a medical AI solution designed to predict patient deterioration at an early stage using electronic medical record (EMR) data collected within hospitals. The latest approval marks the sixth regulatory authorization obtained by VitalCare globally, including in Korea, further strengthening the company’s expansion into international markets, particularly across Southeast Asia. The approval follows the company’s recent authorization in Indonesia.

The newly obtained certification corresponds to a Class C medical device under Malaysia’s medical device classification system, indicating that the product underwent a rigorous review process evaluating its safety and effectiveness.

Malaysia has been accelerating the adoption of digital healthcare initiatives at the national level, expanding the use of healthcare data and promoting the digital transformation of hospital systems. In particular, the Malaysian Ministry of Health has been gradually building healthcare data infrastructure -- including EMR systems, Electronic Lifetime Health Records (ELHR) and Health Information Exchange (HIE) platforms -- in line with the “Health White Paper” policy document announced in 2023.

As the healthcare sector increasingly leverages medical data, opportunities are growing for AI-based solutions to identify high-risk patients early and support rapid clinical intervention. AITRICS expects VitalCare to contribute to strengthening patient safety management systems within Malaysian healthcare settings through this approval.

The company stated that the authorization demonstrates that VitalCare’s technological capabilities and product quality have been officially recognized by overseas regulatory authorities. It added that the approval further confirms the solution’s safety and effectiveness across various healthcare environments and regulatory frameworks.

“As healthcare data infrastructure expands, the key question is how such data can be effectively utilized in real clinical settings to improve patient safety,” AITRICS CEO Kim Kwang-joon said. “We hope VitalCare will establish itself in Malaysian hospitals as a solution that enables healthcare professionals to detect patient risk signals more quickly and support rapid clinical decision-making and response.”

Kim Ji-hye