Ministry of Food and Drug Safety approves Korea’s first generative AI-based digital medical device

MFDS Grants First-Ever Approval for a Generative AI-Based Digital Medical Device in South Korea

First approval and review guidelines applied under the Digital Medical Products Act enacted last year

The Ministry of Food and Drug Safety (MFDS, Commissioner Yu-kyoung Oh) announced on April 1 that it has approved a digital medical device that assists radiologists in interpreting chest X-ray images by generating preliminary reports* using generative artificial intelligence technology.

* Covering 57 conditions including pleural effusion, pneumothorax, pulmonary edema, pulmonary nodules, cardiomegaly, active tuberculosis, rib fractures, and clavicle fractures

Unlike existing AI-based digital medical devices that were limited to indicating the location of lesions, the presence or absence of disease, and severity levels on chest X-ray images, this product is the first generative AI-powered digital medical device in South Korea that directly provides text-based preliminary reports by analyzing abnormal findings in the images using generative AI technology.

Clinical trial results, in which five experienced radiologists conducted comparative evaluations using actual chest X-ray interpretation reports as the control group, demonstrated that the product maintains a level of performance comparable to that of radiologists in real clinical settings.

This approved product received proactive, tailored regulatory support from clinical trial design through to approval, applying the "Generative AI Medical Device Approval and Review Guidelines" — the world's first such guidelines — published by MFDS under the Digital Medical Products Act enacted last year.

MFDS expressed its expectation that this approval will help medical professionals in drafting radiology interpretation reports for chest X-rays. The agency also stated that it will continue to strengthen the global competitiveness of the digital medical device sector and remain committed to improving public health through prompt approval and review of AI-based medical devices.