[Edaily Reporter Kim Hyung-il ] #SGHEALTHCARE CO.,LTD. announced on the 29th that it has received notification from the U.S. Food and Drug Administration (FDA) that it has initiated a full review of its 510(k) application for “AriaMR,” an artificial intelligence (AI)-based MRI image reconstruction solution.

AriaMR is a next-generation AI-based image reconstruction solution that utilizes deep learning algorithms to reduce MRI scan times to one-fourth while effectively removing noise to produce high-resolution images. Developed in 2022 by SGHEALTHCARE CO.,LTD. in collaboration with the Korea Advanced Institute of Science and Technology (KAIST) through its subsidiary Mint Labs, the technology offers the advantage of immediately upgrading performance simply by installing the software, without the need to replace existing MRI equipment.

Notably, SGHEALTHCARE CO.,LTD. initially applied for FDA approval for the AI solution under the name “IAI,” but changed the product name to AriaMR to strengthen its identity in line with FDA guidelines and facilitate global market entry. The company also submitted the application multiple times and made repeated revisions to incorporate enhanced FDA cybersecurity requirements and other updates.

SGHEALTHCARE CO.,LTD. stated, “After obtaining approval for AriaMR from the Ministry of Food and Drug Safety (MFDS) in Korea, we achieved our first commercialization and overseas exports in 2023. Once this FDA 510(k) approval is finalized, we plan to begin full-scale expansion into North America, the world’s largest healthcare market.”