MFDS approves 2 AI-based medical devices developed in Korea

Published: 2018-08-22 16:50:42

Updated: 2018-08-22 16:50:55

The Ministry of Food and Drug Safety announced approval of the AI-powered medical image analysis software ‘Lunit INSIGHT’ and the AI-based stroke diagnostic supporting system ‘JBS-01K’ developed by ‘Lunit’ and ‘JLK INSPECTION’ respectively on 14 August.

These approved products have been selected as subject to the ‘Approval and Assessment Guidelines for Big Data & AI-applied Medical Devices’ si...

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