Portable MRI System Gains CE Mark for Point-of-Care Brain Imaging

Diffusion-weighted imaging is central to stroke diagnosis but traditionally requires transport to a fixed scanner. A newly approved system addresses this gap by enabling point-of-care brain MRI with enhanced diffusion capabilities following CE Marking and UK Conformity Assessment (UKCA) approval.

Hyperfine’s next-generation Swoop system and the latest advancement in its Optive AI software are the focus of the approvals. The Swoop platform is a portable, ultra-low-field MRI system cleared by the U.S. Food and Drug Administration (FDA) for brain imaging in patients of all ages. Optive AI software is integrated with the system to enhance image quality and ease of use.

The software introduces a multi-direction diffusion-weighted imaging (DWI) sequence that acquires and averages images from multiple diffusion directions, similar to methods used with high-field scanners. This approach yields cleaner, more consistent images that are especially useful for stroke assessment, aiding better detection of small strokes and supporting acute neurological care. The software ships with the next-generation system and is also available as a standalone upgrade for existing users.

CE Marking and UKCA approvals for both the next-generation Swoop system and the latest Optive AI software enable commercialization across the European Economic Area and the United Kingdom. The Swoop system is currently commercialized in these markets through distributors operating in more than a dozen countries. Commercial rollout of the newly approved products in Europe and the U.K. is planned to begin in early third quarter 2026.

The next-generation Swoop scanner received FDA clearance in the second quarter of 2025, and the Optive AI software followed in December 2025. In the United States, next-generation systems have been placed in critical care and emergency departments as well as neurology offices. The portable systems are intended to image the head at the point of care when a full diagnostic examination is not clinically practical.

“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. 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,” , said Maria Sainz, President and CEO of Hyperfine. 

"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,” said Sainz.