South Korean device company AIRS Medical has gained CE certification for its artificial intelligence (AI)-powered multi-resonance imaging (MRI) enhancement solution, SwiftMR.
AIRS Medical received 510(k) clearance from the US Food and Drug Administration (FDA) in October 2023.
SwiftMR utilises deep learning technology to enhance MRI image quality, reducing image scan times by up to 50% and improving productivity without requiring additional scanner upgrades or purchases.
In the announcement accompanying the certification, CEO of AIRS Medical Hyeseong Lee said: “Our MDR CE certification clearly shows AIRS Medical’s capabilities in product quality and regulatory compliance. Through this certification, we will accelerate our market growth in the European market.”
According to a report on GlobalData’s Medical Intelligence Center, the AI in medical market was worth $336m in 2022 and is expected to grow at a CAGR of 29.1% to $1.2bn by 2027.
A Medical Device Network insight highlights that AI-assisted MRI is a key innovation area in AI, improving surgical and exam planning, image reconstruction, image analysis, and supporting clinical decision making.
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In October last year, VUNO gained FDA clearance for its Med-DeepBrain AI tool that characterises brain structures from MRI scans. The algorithms observe 100 brain regions and provide volumetric data on the structures, cortical thickness, and white matter hyperintensity. The company highlighted that the platform could be used to detect dementia and other neurodegenerative diseases in the early stages because the AI can present quantifiable brain data from the patient that had been compared with a normal population.
Earlier in 2023, Ezra won FDA 510(k) clearance for its AI technology Ezra Flash, for use in brain imaging. Ezra trained the AI to identify the most important components of an MRI scan that are required to produce a complete and precise image.