First AI-based medical device gains government approval in South Korea

South Korea’s Ministry of Food and Drug Safety announced this week that, for the very first time, it has approved a medical device that uses artificial intelligence (AI) technology.

The device, VUNO’s VUNOmed-BoneAge, was developed to determine a patient’s bone age by studying x-ray images, according to a report from Korea Biomedical Review. The approval came after a clinical trial confirmed the device’s effectiveness.  

“Both the company and the ministry expect the invention will shorten the reading time by automating the manual reading of the bone age,” wrote author Lee Han-soo.

Korea Biomedical Review also reported that three other medical devices related to AI and big data are currently going through clinical trials.

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