Hyperfine, Inc has obtained CE Marking and UK Conformity Assessment (UKCA) approval for its next-generation Swoop® system and the latest advancement in its Optive AI™ software.
The approvals enable commercialisation across the European Economic Area and the United Kingdom, marking a key step in the company’s international expansion strategy.
The next-generation Swoop® system, cleared by the U.S. FDA in Q2 2025, delivers improved image quality, streamlined workflow, and enhanced usability for point-of-care brain imaging.
The system has already seen adoption in critical care units, emergency departments, and neurology clinics in the United States.
Regulatory approval also extends to the updated Optive AI™ software, which received FDA clearance in December 2025.
The software introduces a multi-direction diffusion-weighted imaging (DWI) sequence that improves image clarity and consistency, supporting more accurate detection of small strokes and strengthening diagnostic capability in acute neurological settings.
It is available both as part of the next-generation system and as an upgrade for existing users.
Hyperfine plans to begin European and UK commercial rollout in early Q3 2026 through its distributor network across more than a dozen countries.
