AIRS Medical has secured EU Medical Gadget Regulation (MDR) CE certification for its SwiftMR AI-powered MRI enhancement resolution.
This certification marks a big milestone, allowing the sale of SwiftMR throughout the EU’s 27 nations, Turkey, the Liechtenstein, Iceland, Norway (EEA), Nice Britain and Switzerland.
The MDR CE certification represents a extra rigorous set of necessities for medical gadgets in contrast with the earlier Medical Gadget Directive (MDD). It ensures elevated requirements of efficiency, high quality, security and medical analysis, the corporate mentioned.
AIRS Medical’s flagship product SwiftMR is designed to reinforce MRI picture high quality by utilising superior deep studying know-how.
It will probably cut back MRI scan occasions by as much as 50% and enhance picture high quality via AI-powered denoising and sharpening strategies.
A big advantage of SwiftMR is its capability to spice up MRI productiveness with out necessitating new scanner purchases or upgrades to current MRI techniques.
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Having already been carried out in additional than 14 nations, SwiftMR has processed greater than 1.1 million exams throughout greater than 300 establishments.
The latest MDR CE certification is anticipated to additional drive the answer’s enlargement within the European market.
AIRS Medical CEO Hyeseong Lee mentioned: “Our MDR CE certification clearly reveals AIRS Medical’s capabilities in product high quality and regulatory compliance.
“By this certification, we are going to speed up our market progress within the European market.”
In October 2023, AIRS Medical secured approval from Japan’s Prescribed drugs and Medical Units Company for the SwiftMR resolution.
The corporate, to expedite world market entry, achieved Medical Gadget Single Audit Program approval comprising 5 totally different nations together with Japan.
It is usually engaged on an AI-powered Venipuncture automation resolution, which is because of be launched quickly.