South Korea has granted its first approval for a digital medical device powered by generative artificial intelligence. The device analyzes chest X-ray images and summarizes abnormal findings in text form, representing an advancement beyond conventional image-analysis AI.
The Ministry of Food and Drug Safety (MFDS) said Thursday it has approved a digital medical device that generates preliminary findings based on chest X-ray images. The product analyzes a total of 57 types of lesions, including pleural effusion, pneumothorax, pulmonary edema, lung nodules, cardiomegaly, active tuberculosis and fractures.
While existing AI medical devices were limited to marking lesion locations on images or classifying the presence of diseases, the newly approved product uses generative AI to comprehensively analyze abnormal findings in images and present the results in sentence form. Medical professionals can then reference these preliminary findings during their readings.
Clinical trials confirmed the device's similarity to actual radiological readings. In a comparative evaluation by five experienced radiology specialists, the preliminary findings generated by the device maintained a level comparable to clinical readings in practice.
The approval is also significant from a regulatory standpoint. It marks the first case in which the MFDS applied its review guidelines for generative AI medical devices, established under the Digital Medical Products Act that took effect last year. Given that reliability and reproducibility of results are critical for generative AI, the approval demonstrates that a preemptive regulatory framework has been built and successfully led to actual product authorization.
In clinical settings, the device is expected to reduce repetitive tasks in chest X-ray reading and improve the efficiency of the interpretation process. "We will continue to strengthen global competitiveness in the digital medical device sector and push for swift approval and review of AI medical devices," the MFDS said.