Korea clears first generative AI device

Korea clears first generative AI device that drafts chest X-ray reports

Soombit.ai's AIRead-CXR, a chest X-ray preliminary report solution, has received Class 3 medical device approval from the Ministry of Food and Drug Safety (MFDS) on Wednesday.

Soombit.ai said that AIRead-CXR is Korea's first generative AI-based software as a medical device (SaMD) for medical imaging. Using about 14 million data points from Korea and abroad, it provides preliminary reports for posterior-anterior (PA) or anterior-posterior (AP) chest X-rays.

The MFDS said it confirmed the device's efficacy and safety by comparing AIRead-CXR-generated reports with those of five experienced radiologists. Clinical trials were conducted at Seoul National University Hospital and Seoul National University Bundang Hospital using over 1,000 chest X-ray cases, leading to validation.

"AIRead-CXR not only provides a high level of diagnostic assistance for 57 core validated findings and diseases, but also interprets and reports various other imaging findings," Soombit.ai said.

Source: KBR (Korea Biomedical Review)