AITRICS-VC (VitalCare)

Where does the US clearance stand?

K240756 is dated July 23, 2024, under the applicant name Aitrics Co., Ltd., for "AITRICS-VC" (21 CFR 870.2300, product code PLB, "Multivariate Vital Signs Index"). The predicate is Capsule Surveillance System (K213335). Korean press reports an MFDS approval in October 2022, which has not been verified on an official page. The homepage lists the Malaysian MDA and Indonesian Ministry of Health approvals instead of the US one.

What does the cleared software do?

The FDA indication describes stand-alone software that analyzes patient data from the EHR and displays in-hospital patients whose vital signs, laboratory values or conventional early warning scores (MEWS, NEWS, qSOFA) exceed thresholds. It does not replace bedside monitors and is not for ICU or operating room use. Korean press describes the underlying risk model as predicting sepsis, death and cardiac arrest. The Korean homepage, translated, reads "AI analyzes real-time EMR data accumulated in hospitals to predict patient deterioration". No EHR vendor is named.

Planned work under an "AX" project with Gangbuk Samsung Hospital covers outpatient record summaries, CT and MRI report summaries and nursing handover support. A clinician copilot called V.Doc Pro appears in Korean press.

Which papers name VitalCare?

Six 2025 and 2026 papers on deterioration and sepsis models name VitalCare in the title or abstract, and their author affiliations have not been checked. Three examples:

• PMID 40494595 (Acute and Critical Care, 2025), prospective external validation of a deep-learning early warning system for major adverse events in general wards.
• PMID 40541404 (BMJ Health & Care Informatics, 2025), an AI algorithm for sepsis risk stratification.
• PMID 40845828 (JMIR Medical Informatics, 2025), deep-learning early warning for code blue events and length of stay.

PMID 42513667 (J Clin Med, 2026), on a workload-constrained cutoff for deterioration AI, is also listed on the vendor's site, and several of the six are vendor-linked.

Company and funding

AITRICS Inc. is in Gangnam-gu, Seoul, with Kim Kwang-jun as CEO. Korean press gives 2016 as the founding year, a Series B of KRW 27.1 billion in March 2024 and a Series C of KRW 35 billion announced on December 1, 2025. The homepage names memoranda of understanding with the HKU Faculty of Medicine CHART and Glen Eagles Hospital in Hong Kong, and a mention in TIME's "World's Best Health Tech Companies 2026". It gives no customer count and no price.

The verdict

The verifiable footprint is the Malaysian and Indonesian approvals the homepage lists, the Hong Kong memoranda and the July 2024 US clearance, while the Korean MFDS approval is unverified. Author affiliations on the six papers are unchecked, which leaves independent validation an open question.