M4CXR Becomes First Generative AI-Based Medical Device Designated as Innovative Medical Device by Ministry of Food and Drug Safety

Deepnoid, a first-generation medical artificial intelligence (AI) company in Korea, announced on November 27 that its 'M4CXR' has been designated as the first generative AI-based medical device to receive the Advanced Technology Group Innovative Medical Device status (No. 119) from the Ministry of Food and Drug Safety.

'M4CXR' is a generative AI-based chest X-ray report draft generation solution developed in-house by Deepnoid. It analyzes chest X-ray images taken for the purpose of diagnosing and screening chest diseases and drafts a preliminary report within seconds, covering normal findings and 41 types of abnormal findings related to chest diseases. The solution received approval for its clinical trial plan (IND) in August 2025, has completed clinical trials, and is currently undergoing the regulatory approval process with the Ministry of Food and Drug Safety.

The Innovative Medical Device designation is granted to medical devices that are expected to demonstrate improved safety or efficacy compared to existing devices, thanks to the application of advanced, high-technology features or improvements in usage methods. Designated products benefit from institutional advantages under the 'Medical Device Industry Promotion and Innovative Medical Device Support Act,' including priority and phased reviews and customized technical consultations during the approval process.

Deepnoid previously received its first Innovative Medical Device designation in 2023 for its brain vascular disease diagnostic support AI solution, 'Deep:NEURO.' Last year, it also obtained a non-reimbursed health insurance code as an innovative medical technology. This latest designation marks the second Innovative Medical Device recognition for the company, reaffirming the innovative nature of Deepnoid's medical AI solutions.

Choi Woosik, CEO of Deepnoid, stated, "We see great significance in M4CXR being the first generative AI-based medical device to be designated as an Innovative Medical Device. Since we have already completed clinical trials and are in the process of obtaining regulatory approval, we expect it will soon significantly improve work efficiency for medical professionals in clinical settings."

Deepnoid recently completed a demonstration project applying a domestically produced NPU to M4CXR, in collaboration with FuriosaAI, with support from the 'AI Semiconductor Application Demonstration Support Project' led by the National IT Industry Promotion Agency (NIPA). Starting with M4CXR, the company plans to expand its generative AI-based solutions to other modalities such as computed tomography (CT) and magnetic resonance imaging (MRI), as well as broaden the clinical application scope to cover a wider range of diseases.