South Korea has approved its first generative artificial intelligence (AI) medical device, marking a significant milestone in healthcare technology. The Ministry of Food and Drug Safety granted the approval following clinical trials that demonstrated the device’s ability to interpret X-ray images with accuracy comparable to that of experienced radiologists.
On Wednesday, the Ministry announced the approval of AI Read X-ray (CXR), a digital medical device developed by Soom Bit AI. This innovative tool uses generative AI technology to analyze chest X-ray images and produce preliminary reports, assisting radiologists in their diagnostic process.
Unlike previous AI medical devices that simply highlighted lesions, identified diseases, or indicated severity in chest X-rays, this groundbreaking product is the first in South Korea to employ generative AI. It goes a step further by analyzing images and generating detailed preliminary reports in text format.
The device’s efficacy was validated through rigorous clinical trials. Five seasoned radiologists compared the AI-generated interpretations against standard radiological reports, confirming that the device’s performance closely matches that of human experts in X-ray image interpretation.
Moreover, the product’s development benefited from proactive regulatory support. It was guided by the world’s first Guidelines for the Approval and Review of Generative AI Medical Devices, published last year under South Korea’s Digital Medical Products Act. This support extended from the clinical trial design phase through to the final approval process, showcasing the country’s commitment to advancing medical AI technology while ensuring patient safety.