Hyperfine's portable Swoop MR scanner.
Hyperfine has announced new partnerships with distributors in France, the U.K., and Italy to extend the reach of its Swoop portable MR system across European markets. This expansion follows the company's receipt of CE certification under the EU MDR, and UKCA certification in the U.K. for its most advanced hardware and AI-powered software.
Swoop, unique for its portable and relatively inexpensive affordability, has a .064 Tesla magnet and requires no shielding. It is meant to enhance, and expand access to, brain imaging capabilities. The technology is particularly aimed at expanding clinical applications from hospital critical care units to outpatient clinics and medical offices, with potential use in treating conditions like Alzheimer’s disease and acute stroke.
“These strategic distributor partnerships enable a broader market footprint for our business beyond our direct commercial team in the U.S.,” said Maria Sainz, president and CEO of Hyperfine Inc. “We are very encouraged by the high interest level and positive feedback from international clinicians thus far.”
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The Connecticut-based company has also expanded its leadership team, appointing industry veteran Enrico Barini as international business development director. Barini, who brings extensive experience from previous roles at ViewRay Inc. and Boston Scientific, will spearhead the Swoop system's market introduction in Europe.
Hyperfine's Swoop Portable MR Imaging system is the first of its kind to be FDA-cleared for brain imaging across all ages and is now commercially available in select markets. Its design enables diagnostic examination in locations where traditional MR imaging is unfeasible, thereby broadening the possibilities for patient care and clinical diagnosis.
Last month, the company launched a study to assess the
effectiveness of Swoop for detecting amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients undergoing amyloid-targeting therapy aimed at reducing amyloid plaques in the brain.