Hyperfine Inc. (NASDAQ: HYPR) received CE Marking and UK Conformity Assessment approval for its next-generation Swoop portable MRI system and latest Optive AI software, according to a company statement.

The approvals enable commercialization of the brain imaging technology across Europe and the United Kingdom. The next-generation Swoop system received FDA clearance in the second quarter of 2025, while the updated Optive AI software was cleared by the FDA in December 2025.

The new Optive AI software includes multi-direction diffusion-weighted imaging that acquires and averages images from multiple diffusion directions. This capability produces images that may be valuable for stroke diagnosis by enabling detection of small strokes.

The system is currently distributed through a network spanning over a dozen countries in the European Economic Area and United Kingdom markets. In the US market, Hyperfine has placed systems in critical care units, emergency rooms, and neurology offices.

"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.

The company plans to begin commercialization of the next-generation system and software in Europe and the UK in early third quarter of 2026. The Swoop system is FDA-cleared for brain imaging of patients of all ages and is designed to provide imaging at multiple points of care.