• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.881-887
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• 2023

This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

• Journal of the Korean Society of Radiology
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• v.85 no.4
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• pp.693-704
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• 2024

Artificial intelligence (AI) technology is actively being applied for the interpretation of medical imaging, such as chest X-rays. AI-based software medical devices, which automatically detect various types of abnormal findings in chest X-ray images to assist physicians in their interpretation, are actively being commercialized and clinically implemented in Korea. Several important issues need to be considered for AI-based detection assistant tools to be applied in clinical practice: the evaluation of performance and efficacy prior to implementation; the determination of the target application, range, and method of delivering results; and monitoring after implementation and legal liability issues. Appropriate decision making regarding these devices based on the situation in each institution is necessary. Radiologists must be engaged as medical assessment experts using the software for these devices as well as in medical image interpretation to ensure the safe and efficient implementation and operation of AI-based detection assistant tools.