Soombit.ai has received Investigational New Drug (IND) approval from the Ministry of Food and Drug Safety (MFDS) to initiate a pivotal clinical trial evaluating the safety and efficacy of AIRead-CXR - Korea´s first generative AI-based medical device to reach this stage.

The approved study is a multicenter, retrospective, randomized, crossover, third-party-blinded, pivotal clinical trial designed to assess AIRead-CXR, our generative AI solution for preliminary chest X-ray interpretation.

Our innovation aims to empower radiologists by enhancing their expertise and supporting more efficient and accurate diagnoses.