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Hyperfine’s Swoop Portable MRI Receives CE Mark

The clearance was granted under the new EU Medical Device Regulation (MDR).

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By: Sam Brusco

Associate Editor

Hyperfine, creator of the Swoop FDA-cleared portable MRI system, has gained CE marking for the product. The company said it will maintain commercial focus in the U.S., but that CE marking enables potential future commercial expansion into the European economic area.
 
The CE mark was granted under the new European Commission Regulation (EU) No. 2017/745, commonly known as the Medical Device Regulation (MDR). Recent MDR mandates raised the bar for manufacturers, requiring them to meet more stringent guidelines and placing greater importance on a clinical evaluation report (CER).
 
“Receiving CE marking for our portable MRI system with AI-powered imaging software is a significant achievement for our company and enables opportunities for future geographic expansion beyond our current commercial focus in the United States,” Maria Sainz, president and CEO of Hyperfine told the press. “The standard for bringing medical devices to market in the EU has become significantly more stringent under the new MDR regulations, and we are proud to have accomplished compliance with these demanding standards.”

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