Seoul approves 2 new AI-based medical devices - Korea Biomedical Review

The Ministry of Food and Drug Safety said it has approved two additional artificial intelligence based medical devices – Lunit's Lunit Insight and JLK Inspection's JB-01K – on Aug. 14. The approval comes after the ministry approved the first AI-based medical device, VUNOmed-BoneAge, in May. The licensed products went through the ministry's new guidelines for approval and examination of medical devices that use big data and artificial intelligence technology. Both devices received customized support and received approval within 60 days of submitting their applications. The Lunit Insight inputs and analyzes the chest images of a patient's X-ray and displays the degree of the suspected pulmonary nodule, which in turn helps doctors diagnose pulmonary nodule.