SEOUL, South Korea-based AIRS Medical has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution, SwiftMR™, which will be sold in 27 EU countries, Turkey, EEA (Liechtenstein, Iceland, Norway), Great Britain, and Switzerland.
SwiftMR™ enhances MRI image quality through fine-tuned deep learning technology and has been deployed in over 14 countries, with more than 1.1 million exams processed in over 300 institutions. It is capable of reducing MRI scan times by up to 50 percent while improving image quality through AI-based noise reduction and sharpening, enabling improved MRI productivity without the need to purchase additional scanners or upgrade existing MRI systems.
The MDR CE certification clearly demonstrates AIRS Medical’s capabilities in product quality and regulatory compliance, and we will accelerate our market growth in the European market.” said Hyeseong Lee, CEO of AIRS Medical.
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