SG Healthcare (CEO Kim Jeong-su) , a specialized imaging diagnostic medical device company, announced on the 7th that it has applied for approval from the U.S. Food and Drug Administration (FDA) for its artificial intelligence (AI)-based magnetic resonance imaging (MRI) software 'IAI'. With this, SG Healthcare has begun its full-scale entry into the global market.
'IAI' is an innovative software that applies AI algorithms that have learned hundreds of thousands of clinical image data to the MRI image acquisition process, reducing the shooting time from the existing 20 minutes to 5 minutes and improving image quality. In particular, it is evaluated to have greatly increased field usability by removing image noise and minimizing distortion.
In addition, 'IAI' can be applied immediately without replacing existing MRI equipment, so it has the advantage of cost reduction as it allows for upgrades without changing equipment.
SG Healthcare said it has submitted technical documents and clinical data for this FDA approval application and is currently preparing supplementary data and other details for future review. It also plans to accelerate market entry by expanding distribution channels in the United States.
CEO Kim Jeong-su said, “IAI’s FDA 510(k) approval application is a signal of technological advancement and global expansion,” adding, “It has already been installed in over 10 countries, and as we have proven the commercialization potential of AI-based imaging diagnostic technology, we will continue to expand our presence in the global market going forward.”
SG Healthcare established its subsidiary Mint Labs in 2021 and began developing medical AI software in collaboration with the Korea Advanced Institute of Science and Technology (KAIST), completing the development of 'IAI' in 2022. It then received product approval from the Ministry of Food and Drug Safety (MFDS) in the same year and achieved its first commercialization and overseas export in 2023.
Meanwhile, the MRI equipment 'INVICTUS' with 'IAI' technology applied is attracting attention from the industry by adopting a 1.5T magnetic field, high-definition images, and a helium-free magnet that does not require helium.
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