AIRS Medical Secures EU Certification for Flagship Product SwiftMR™: What it Means

Scanning centers across Europe and its neighboring countries can now offer patients groundbreaking artificial intelligence (AI)-powered magnetic resonance imaging (MRI) technology. The European Union (EU) Medical Device Regulation (MDR) has granted SwiftMR™ CE mark, meaning it can be sold across all EU member states plus Iceland, Liechtenstein, and Norway.

What is CE Mark?

The “CE” label can be found on an array of products ranging from appliances and toys to machinery and medical devices. It signifies that the product meets the highest safety, health, and environmental standards, as determined by the MDR.

“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.”
– Hyeseong Lee, CEO

It’s important to note that not all medical devices are awarded MDR CE certification. If you operate a scanning center in a European Economic Area (EEA) country, you can rest assured knowing that SwiftMR™ satisfies the most stringent regulatory requirements.

How does this Impact Your Facility?

If you operate an MRI center in the EU or a neighboring country, you can now attain all of the benefits of SwiftMR™:

  • Uncompromising quality: AIRS Medical is committed to building top-notch products that not only meet but exceed industry standards.
  • Relentless innovation: AIRS Medical is on the forefront of the AI revolution in diagnostic imaging, as SwiftMR™ utilizes deep learning technology to enhance MRI image quality and speed.
  • Trustworthy technology: SwiftMR™ is already a globally recognized technology found in over 300 locations across 15 countries. AIRS Medical was recently named a top digital health company.
  • Cost savings: Because SwiftMR™ accelerates scan times by up to 50%, scanning centers can scan more customers without additional equipment costs.

Get Better Scans, Faster

Internationally recognized as the quickest and most accurate MRI enhancement tool, SwiftMR™ is your key to better diagnostics and revenue growth. Want to learn more about how we’re revolutionizing MRI? Contact us today.