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Korea's first AI medical device MFDS approval is just around the corner.

  • 2018. 02. 08


Korea's first Artificial Intelligence (AI) diagnostic support system has been approved.  

As early as next month, it will be used in the hospital treatment process. It is expected to become widely

implemented and improve the quality of medical services. 

VUNO Med®-BoneAge is the first AI-based diagnostic software in the Korean market for bone age assessment.

There is now no need to compare with a reference book. The G.P.-based AI provides accurate assessment of

bone age from the hand X-ray images.


In September last year, VUNO has applied to the Ministry of Food and Drug Administration for approval as a

second-class medical device. The second class device designation is for low-potential risk medical devices.

VUNO conducted clinical trials to verify the reliability and efficacy of VUNO Med®-BoneAge with

Asan Medical Center. Recently, clinical trial were successfully completed and final results reports were submitted.

VUNO Med®-BoneAge has the highest chance of becoming South Korea's first AI medical diagnosis

support system early next month.