Hyperfine has obtained CE marking and U.K. Conformity Assessment (UKCA) approval for its next-generation Swoop portable MR system and updated Optive AI software, clearing the way for commercialization across Europe and the United Kingdom.

The Guilford, Connecticut-based company said the approvals cover both its latest hardware platform and a software upgrade designed to expand clinical utility, particularly in neurological care. The system had previously received FDA clearance in 2025.

Portable MR systems such as Swoop are designed for use at the point of care, particularly in settings where conventional MR scanners are not readily accessible. The devices operate at ultralow magnetic field strength and are intended to provide imaging of the brain when full diagnostic MR exams are not practical.
The updated Swoop device introduces improvements in image quality and workflow compared with earlier versions. It has already been deployed in U.S. critical care settings, emergency departments and neurology practices, according to the company.

The newly approved Optive AI software includes a multi-direction diffusion-weighted imaging sequence, a technique commonly used in high-field MR systems. By capturing and averaging images from multiple diffusion directions, the feature is intended to produce more consistent scans and improve the detection of small strokes. The software can be installed on new systems or deployed as an upgrade for existing users.

Hyperfine said the approvals apply across the European Economic Area and the U.K., where the company currently operates through a distributor network spanning more than a dozen countries.

“We are proud to bring our most innovative technology to clinicians and patients in Europe and the U.K., 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 commercial rollout of the system and software in the region in the third quarter of 2026.

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