Breakthrough in Neonatal Care: AI-Powered Software Approved for Managing Growth Retardation in Extremely Low Birth Weight Infants

The Ministry of Food and Drug Safety has announced the approval of a groundbreaking software, BT-580AI, developed by Bistos, designed to manage the risk of growth retardation in extremely low birth weight infants.

This innovative software medical device utilizes artificial intelligence to analyze one week’s health information data of extremely low birth weight (1.5 kg or less) infants admitted to the neonatal ward. The AI-powered technology then indicates the risk of growth retardation at the time of discharge (up to 28 days) as either ‘high (high risk group)’ or ‘low (low risk group)’. This pioneering software is the first of its kind in Korea to receive approval for growth retardation management in extremely low birth weight infants.

According to the Ministry of Food and Drug Safety, the predicted risk of growth retardation in extremely low birth weight infants, as determined by this software, will enable medical staff to provide targeted and intensive management. This includes enhanced nutritional supply, ultimately contributing to the healthy growth and development of these vulnerable infants.

The Ministry of Food and Drug Safety remains committed to supporting the development and supply of innovative software medical devices, leveraging artificial intelligence and regulatory science expertise. This commitment aims to expand treatment opportunities for diseases that were previously challenging to diagnose and predict.