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AITRICS Obtains Medical Device Approval for AITRICS-VC(VitalCare) in Indonesia

2026-04-09

Secures Regulatory Approvals in Five Markets Including the U.S., Vietnam, and Hong Kong,

Accelerating Expansion in Southeast Asia


 

 

 

 

  

[April 9, 2026] AITRICS, a medical artificial intelligence (AI) company, announced on April 9 that it has obtained medical device approval from the Ministry of Health of the Republic of Indonesia (MoH) 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. In general wards, the solution predicts the risk of major adverse events — including death, ICU transfer, and cardiac arrest — as well as sepsis and cardiac arrest. In intensive care units, it predicts mortality risk, helping clinicians rapidly identify high-risk patients and respond proactively.

The Indonesian Ministry of Health recently announced its 2025–2029 Digital Health Transformation Strategy(DHTS), under which it is actively advancing the development of smart hospitals and the broader adoption of AI-based standalone Software as a Medical Device(SaMD) centered on SATUSEHAT, the country’s integrated health data platform.

As the most populous country in Southeast Asia, Indonesia is rapidly building out its digital healthcare infrastructure. With a nationwide health data platform serving as the foundation for data connectivity and interoperability across healthcare institutions, the environment for the adoption of medical AI is also expanding.

Against this policy backdrop, AITRICS expects this approval to further accelerate its entry into the Southeast Asian market. With this latest approval in Indonesia, AITRICS-VC(VitalCare) has now secured regulatory approvals in a total of five markets, Korea, the United States, Vietnam, Hong Kong, and Indonesia, establishing a stronger foundation for global expansion. The company plans to build on this momentum to further expand into additional overseas markets.

Kwangjoon Kim, CEO of AITRICS, stated, “This approval is meaningful not only as a market entry milestone, but also as validation that AITRICS-VC(VitalCare) can be deployed across diverse healthcare environments and regulatory systems”, said “It is particularly significant in that it aligns with the Indonesian Ministry of Health’s policy direction for digital healthcare innovation. Moving forward, we will continue to expand our global business based on our accumulated clinical data and regulatory experience.” 
 
Following this approval, AITRICS plans to continue fulfilling post-market regulatory requirements in Indonesia while also advancing approval procedures in Singapore and Malaysia to further strengthen its presence in Southeast Asia.