AIRS Medical, a leading AI-powered healthcare solution provider, has recently received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution called ‘SwiftMR’. This certification allows AIRS Medical to sell ‘SwiftMR’ in various countries, including the EU, Turkey, EEA, Great Britain, and Switzerland. The MDR CE certification is known for its stringent requirements, ensuring higher performance, quality standards, safety, and clinical evaluation.
By obtaining the MDR CE certification, AIRS Medical has demonstrated its adherence to the strict European standards for product performance, safety, and quality. This certification comes on the heels of the FDA 510(k) expanded approval received by the company in October 2023, making it a notable achievement in the AI medical device industry.
‘SwiftMR’ is an AI-powered MRI enhancement solution that utilizes deep learning technology to enhance the image quality of MRI scans. It has the capability to reduce MRI scan times by up to 50%, while also improving image quality through AI-powered denoising and sharpening techniques. One of the major advantages of ‘SwiftMR’ is that it allows for improved MRI productivity without the need for additional scanner purchases or upgrades.
‘SwiftMR’ has already been adopted in over 14 countries and has processed over 1.1 million exams in more than 300 institutions. With the recent MDR CE certification, the market expansion of ‘SwiftMR’ is expected to further accelerate in Europe. AIRS Medical will also be showcasing its latest achievements through an AI Theater Presentation at the European Congress of Radiology 2024.
Hyeseong Lee, the CEO of AIRS Medical, expressed his satisfaction with the MDR CE certification, stating that it validates the company’s capabilities in product quality and regulatory compliance. He also mentioned that this certification will help accelerate their market growth in Europe.
AIRS Medical is a leading healthcare AI company that aims to transform the medical industry through innovative technology, making healthcare more accessible to people when they need it. In addition to ‘SwiftMR’, the company is also working on an AI-Powered Venipuncture automation solution, which will be released in the near future.
For more information about AIRS Medical and its products, visit their website airsmed.com.
Contact: Marketing / marketing@airsmed.com / +82-70-7777-5061
