[May 12, 2026] AITRICS, a medical artificial intelligence (AI) company, announced on May 12 that it has obtained medical device approval from the Medical Device Authority(MDA) of Malaysia for its AI solution for patient deterioration prediction, AITRICS-VC(VitalCare).

AITRICS-VC(VitalCare) is a medical AI solution that leverages electronic medical record(EMR) data from hospitals to predict patient deterioration at an early stage. This marks the sixth regulatory approval for AITRICS-VC(VitalCare), including Korea, further strengthening the company’s foundation for global market expansion, including Southeast Asia, following its approval in Indonesia last month.

The approval obtained in Malaysia falls under Class C according to Malaysia’s medical device classification system and was granted following a rigorous review of safety and effectiveness.

Malaysia is expanding the use of healthcare data and the digital transformation of hospital systems based on its national digital health policies. In particular, the Ministry of Health Malaysia is gradually building healthcare data infrastructure, including electronic medical records(EMR), electronic lifetime health records(ELHR), and a health information exchange(HIE), based on the national healthcare policy document Health White Paper, announced in 2023.

As the foundation for healthcare data utilization continues to expand, the potential use of medical AI solutions that help identify high-risk patients at an early stage and support rapid responses by healthcare professionals is also growing. Against this policy backdrop, AITRICS expects this approval to allow AITRICS-VC(VitalCare) to contribute to strengthening patient safety management systems in Malaysian healthcare settings.

AITRICS explained that this approval represents official recognition from an overseas regulatory authority of the product’s technological capabilities and quality competitiveness. It is also meaningful in that AITRICS-VC(VitalCare) continues to validate its effectiveness and safety across diverse healthcare environments and regulatory requirements.

Kwangjoon Kim, CEO of AITRICS, stated, “As healthcare data infrastructure continues to expand, what becomes increasingly important is how such data can be used in actual clinical settings and connected to patient safety”. He added, “We expect AITRICS-VC(VitalCare) to become a solution in Malaysian healthcare settings that helps detect patients’ risk signs earlier and supports healthcare professionals in making faster decisions and responses”.