Hyperfine secures CE mark for portable MRI system. The Guilford, CT-based company said it will maintain its commercial focus in the U.S. in 2023, CE Marking opens the door for potential future commercial expansion into the European Economic Area (EEA).
The Swoop system received initial clearance in 2020 as a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop system has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, and is also available in New Zealand and Pakistan.
“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,” stated Maria Sainz, president and CEO of Hyperfine, Inc. “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.”