IDE approval

[Seoul, Apr. 7. 2025]

Soombit.ai has received Investigational Device Exemption (IDE) 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.