AIATRICS said Thursday that it has been certified as the “No. 6 Innovative Medical Device Software Manufacturer” by the Ministry of Food and Drug Safety (MFDS).

The “Innovative Medical Device Software Manufacturer” certification system selects and supports excellent companies by evaluating their R&D personnel, organization, and quality management system among products designated as innovative medical devices. Companies that obtain certification receive support for rapid commercialization, including exemptions from some of the materials required for medical device manufacturing permits or manufacturing certification.

AITRICS said the company won approval as the 6th innovative medical device software manufacturer in recognition of its efforts to continuously manage product quality, from the development of “AITRICS-VC (Vital Care),” an artificial intelligence solution for predicting patient deterioration, to establishing systematic analysis procedures for safety and validation, maintenance, and functional issues.

"Currently, ‘Vital Care’ has been introduced and used in about 30 hospitals in Korea, and it is recognized as a product that provides practical help to medical professionals and patients," CEO Kim Kwang-jun said. "We will continue researching to make our products more valuable in the clinical field."

Vital Care is a solution that analyzes electronic medical record (EMR) data collected by default for hospitalized patients to predict death within six hours, unplanned ICU transfers, and cardiac arrest for general ward patients, sepsis risk within four hours for general ward patients, and death within six hours for ICU patients. Vital Care was designated as the “No. 27 Innovative Medical Device” by the MFDS in December 2022.

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