Lunit and Coreline Soft Certified as 'Innovative Medical Device Software Manufacturers' by MFDS

[Asia Economy Reporter Chunhee Lee] Lunit and Coreline Soft have been certified as 'Innovative Medical Device Software Manufacturers' designated by the Ministry of Food and Drug Safety (MFDS).

The MFDS announced on the 2nd that it certified two manufacturers, Lunit and Coreline Post, which assist disease diagnosis using artificial intelligence (AI) technology, as innovative medical device software manufacturers.

Innovative medical device software refers to medical device software that is independently developed and manufactured among products designated as innovative medical devices. Earlier, in April, the MFDS certified Vuno as the first innovative medical device software manufacturer. Lunit developed an innovative medical device (No. 5) that assists diagnosis by detecting abnormal areas in chest images using AI technology, and Coreline Soft developed an innovative medical device (No. 7) that assists diagnosis by analyzing the presence and volume of cerebral hemorrhage in CT images using AI technology.

For this certification, the MFDS formed a private expert and certification evaluation council to review documents and conduct on-site investigations. Through this process, the excellence of the companies' research and development personnel, organization, activities, and manufacturing and quality management systems was evaluated and certified.

Once recognized as an innovative medical device software manufacturer, companies can receive support for rapid product commercialization, such as exemption from submitting materials related to intended use, mechanism of action, and development history during approval applications, and only need to submit software verification and validation data and conformity confirmation reports.

The MFDS provides customized technical support to innovative medical device designated companies to obtain excellent software manufacturer certification, and plans to additionally support companies developing AI-applied technologies such as Parkinson's disease diagnosis assistance, cardiovascular disease risk analysis, cardiac arrest prediction, and sleep apnea diagnosis assistance in the future.

This content was produced with the assistance of AI translation services.