AI-based cardiac arrest prediction software obtains approval as Innovative Medical Device in South Korea

South Korea-based medical AI solutions development company VUNO has obtained approval from the Ministry of Food and Drug Safety (MFDS) for its AI-based cardiac arrest prediction software, VUNO Med–DeepCARS as an Innovative Medical Device. 

The software is specialized in predicting the risk of cardiac arrest and performs a medical analysis of vital signs of patients in general wards stored in the electronic medical records (EMR) including heart rate, respiratory rate, blood pressure, and body temperature. The collection of data forms the basis for predicting the likelihood of an emergency cardiac arrest situation occurring within the next 24 hours.

Clinical testing is underway for VUNO Med–DeepCARS based on a clinical trial plan approved by the MFDS in June.

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According to a research paper published in Critical Care Medicine (CCM) in February, VUNO Med–DeepCARS had a level of sensitivity twice as high as Modified Early Warning Score (MEWS) – a conventional way of cardiac arrest prediction – for the same number of alarms.

THE LARGER TREND

VUNO also recently announced that it was selected to be part of a project, which is led by the National IT Industry Promotion Agency (NIPA) under the Ministry of Science and ICT (MSIT), to technologically demonstrate an AI-run system for medical image-based analysis and diagnosis.

The company plans to develop AI-based medical solutions that can meet the needs of the military environment and prove the accuracy and efficiency in medical image analysis done by military hospitals and medical corps, in partnership with Wonju Severance Christian Hospital and Gachon University Gil Hospital.

In June, VUNO obtained CE Mark for five of its solutions: VUNO Med –BoneAge, VUNO Med –DeepBrain, VUNO Med -Chest X-Ray, VUNO Med –Fundus AI and VUNO Med –LungCT AI, Healthcare IT News reported.

ON THE RECORD

“VUNO Med–DeepCARS makes predictions about cardiac arrest based on a variety of vital signs to allow for early detection and swift response. Obviously, this epoch-making solution will serve as a game changer once it comes into clinical use,” said Hyun-Jun Kim, CEO of VUNO.

He added, “VUNO is dedicated to pioneer groundbreaking AI-based solutions across various medical fields from deep learning-based solutions using medical images to technologies regarding vital signs.”

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