[Edaily Reporter Kim Seung-kwon ] DEEPNOID Inc.(315640)has received product approval from the Ministry of Food and Drug Safety (MFDS) for its generative AI-based medical device, marking the start of its commercialization.

DEEPNOID Inc. announced on the 26th that its generative AI-based chest X-ray preliminary report generation solution, “M4CXR,” has obtained Class 3 medical device approval from the Ministry of Food and Drug Safety (MFDS).

'M4CXR' is a digital medical device that analyzes chest X-ray images using generative AI technology and automatically generates preliminary reports in the form of interpretation texts for 41 types of normal findings and abnormal findings related to chest diseases, thereby assisting in image interpretation.

Last November, it became the first generative AI-based medical device to be designated as an Innovative Medical Device in the Advanced Technology Category (No. 119) by the Ministry of Food and Drug Safety. This approval demonstrates that medical imaging AI is evolving beyond simple lesion detection to a stage where generative AI-based interpretation support can be applied to actual clinical workflows.

DEEPNOID Inc. conducted a multicenter, retrospective confirmatory clinical trial to obtain product approval for “M4CXR.” Through a clinical validity assessment comparing the rate of incorrect diagnoses between interpretation reports written by radiologists and preliminary reports generated by ‘M4CXR,’ the company confirmed that ‘M4CXR’ is not inferior in performance to interpretations by radiologists.

Subgroup analysis results consistently confirmed non-inferiority across all institutions and age groups, and non-inferiority was also demonstrated across the four clinical settings: △outpatient, △emergency, △screening, and △inpatient. This suggests that “M4CXR” can generate preliminary reports of a clinically acceptable standard compared to those of radiologists, even in diverse clinical settings.

DEEPNOID Inc. views this product approval as the starting point for the commercialization of generative AI-based medical devices. The company plans to actively pursue the market launch of “M4CXR” by leveraging its nationwide sales network—which has been systematically managed over the years—and the commercialization experience accumulated through the sale of existing medical AI solutions such as DEEP:NEURO and DEEP:CHEST.

Furthermore, the company plans to expand its modalities from chest X-rays to 3D imaging areas such as chest CT and MRI in the future, thereby systematizing its product lineup as a healthcare-specialized multimodal generative AI solution. Around mid-July, DeepNoid will hold a media day themed “Vision for the Commercialization of Generative Medical AI” to unveil the modality expansion roadmap for its core solutions, including “M4CXR.”

Choi Woo-sik, CEO of DEEPNOID Inc., said, “The competitive edge of ‘M4CXR’ as a generative AI-based medical device lies in its ability to quickly establish itself and spread throughout actual clinical settings.”

He added, “Based on this approval, DEEPNOID Inc. will accelerate the commercialization and market adoption of ‘M4CXR’ and, by expanding its scope of application to include CT and MRI in the future, will lead the generative AI-based medical device market.”