AIRS Medical has secured EU Medical Device Regulation (MDR) CE certification for its SwiftMR AI-powered MRI enhancement solution.
This certification marks a significant milestone, permitting the sale of SwiftMR across the EU’s 27 countries, Turkey, the Liechtenstein, Iceland, Norway (EEA), Great Britain and Switzerland.
The MDR CE certification represents a more rigorous set of requirements for medical devices compared with the previous Medical Device Directive (MDD). It ensures elevated standards of performance, quality, safety and clinical evaluation, the company said.
AIRS Medical’s flagship product SwiftMR is designed to enhance MRI image quality by utilising advanced deep learning technology.
It can reduce MRI scan times by up to 50% and improve image quality through AI-powered denoising and sharpening techniques.
A significant benefit of SwiftMR is its ability to boost MRI productivity without necessitating new scanner purchases or upgrades to existing MRI systems.
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Having already been implemented in more than 14 countries, SwiftMR has processed more than 1.1 million exams across more than 300 institutions.
The recent MDR CE certification is anticipated to further drive the solution’s expansion in the European market.
AIRS Medical CEO 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.”
In October 2023, AIRS Medical secured approval from Japan’s Pharmaceuticals and Medical Devices Agency for the SwiftMR solution.
The company, to expedite global market entry, achieved Medical Device Single Audit Program approval comprising five different countries including Japan.
It is also working on an AI-powered Venipuncture automation solution, which is due to be released soon.