Hyperfine, Inc. (NASDAQ: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced CE mark and UKCA approval for its latest Optive AI™ software update in Europe, further enhancing the capabilities of the Swoop system and supporting broader adoption across medical and emerging brain health applications.
The latest Optive AI software builds on the advances introduced with Model 2, further improving image quality across Swoop system sequences with enhanced noise correction while providing a more intuitive scanning experience with guided workflow.
The software also includes a new isotropic T1 sequence that delivers thinner slices and uniform high resolution across imaging planes, which will strengthen the clinical utility of the Swoop system, particularly in surgical and clinic settings.
The latest technology advancement builds on early commercial progress since Hyperfine's mid-2026 launch of the Swoop system Model 2 in Europe. Within months of launch, Hyperfine has achieved Model 2 sales across four international markets, with flagship institutions in the UK, France, and Romania, among other markets, already using the next-generation Swoop system.
“The European approval of Model 2 was an important milestone in Hyperfine's international growth strategy and early adoption in key European markets demonstrates progress in the company's international commercialization plan,” said Eric Willis, Vice President of International at Hyperfine.
HYPR shares lost 0.1 cents, or 1.9%, to 73.19 cents.
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