AIRS Medical, a leading AI-powered healthcare solution provider, announced that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution ‘SwiftMR’. This certification allows AIRS Medical to sell its flagship product, ‘SwiftMR,’ across the EU (27 countries), Turkey, EEA (Liechtenstein, Iceland, Norway), Great Britain, and Switzerland.
The MDR CE certification is a more stringent requirement for medical devices than the previous Medical Device Directive (MDD), ensuring higher performance, quality standards, safety and clinical evaluation. MDR CE certification is essential for sales in EU and neighbouring countries based on CE certification. However, many companies encounter challenges in obtaining certification and entering Europe due to enhanced assessment requirements and strict standards.
AIRS Medical, by obtaining its initial certification under MDR instead of MDD, has demonstrated adherence to stringent European standards for product performance, safety, and quality. Following FDA 510(k) expanded approval in October 2023, obtaining MDR CE certification is a notably swift pace in the AI medical device industry.
SwiftMR enhances MRI image quality through fine-tuned deep learning technology. It is capable of reducing MRI scan times by up to 50 per cent, while enhancing image quality using AI-powered denoising and sharpening. One of the key advantages of SwiftMR is that it allows for improve MRI productivity without the need for additional scanner purchases or existing MRI upgrades. SwiftMR has expanded into over 14 countries and accumulated over 1.1 million processed exams in over 300 institutions. The recent MDR CE certification is expected to further accelerate market expansion in Europe. Furthermore, AIRS Medical will showcase its latest achievements through an AI Theater Presentation at ECR (European Congress of Radiology) 2024.
Hyeseong Lee, CEO of AIRS Medical, stated, “Our MDR CE certification clearly shows AIRS Medical’s capabilities in product quality and regulatory compliance.” He added, “Through this certification, we will accelerate our market growth in the European market.”
AIRS Medical is a leading healthcare AI company that envisions patient-friendly healthcare by transforming the inefficiencies in the medical industry through innovative technology, enabling more people to access healthcare when needed.