Hyperfine’s Next-Gen Swoop MRI with Latest Optive AI Software Earns EU, UKCA Nods

Hyperfine has received CE mark and UK Conformity Assessment (UKCA) approval for both the next-gen Swoop MRI system and the latest advancement in its Optive AI software.

The next-gen Swoop scanner was cleared by the U.S. Food and Drug Administration (FDA ) in Q2 2025. The company said it is a significant advancement in portable brain MRI, offering improvements in image quality, workflow, and user experience. The next-gen system has created customer interest in the U.S. market, where Hyperfine has placed systems in critical care and emergency rooms at hospitals, as well as in neurology offices.

The company earned European approvals for the latest Optive AI software, which earned an FDA nod in December 2025. The new software features a new multi-direction diffusion-weighted imaging (DWI) sequence that acquires and averages images from multiple diffusion directions, similar to the method used in high-field MRI scanners.

The capability generates cleaner, more consistent images that are valuable for stoke diagnosis, allowing better detection of small strokes. The software is part of the next-gen Swoop system and also available as a standalone software upgrade.

Hyperfine said it plans to begin commercialization of the next-gen Swoop system and latest Optive AI software in Europe and the UK early in Q3 2026.

“We are proud to bring our most innovative technology to clinicians and patients in Europe and the UK and are thrilled to have achieved these approvals ahead of our internal expectations,” said Maria Sainz, president and CEO of Hyperfine. “This milestone is a testament to the exceptional execution of our product and regulatory teams and meaningfully advances a key pillar of Hyperfine’s 2026 international growth strategy. We believe that the next-generation Swoop system will accelerate international adoption of our technology and strengthen our position as the global leader in AI-powered portable brain imaging.”