Hyperfine Receives CE Marking for Swoop® Portable MR Imaging System

Hyperfine, Inc. has achieved CE Marking for its Swoop® system, the world’s first portable MRI system that has received clearance from the FDA. This development enables future potential commercial expansion into the European Economic Area (EEA), while Hyperfine will maintain its commercial focus in the US for 2023.

With AI-powered imaging software, the portable MRI system from Hyperfine has transformed the way diagnostic imaging is conducted, and the CE marking will allow more people access to this cutting-edge technology. The new MDR regulations have made it increasingly difficult to bring medical devices to market in the EU, and meeting these exacting standards is a major achievement for Hyperfine.

The CE Marking was a significant achievement for the company and would enable them to expand into markets beyond the US, said Maria Sainz, the president, and CEO of Hyperfine. “We are proud to have accomplished compliance with these demanding standards, and we believe that the opportunities offered by this achievement will help transform the way medical imaging is conducted worldwide.”