Hyperfine based in California has completed patient enrolment in its multi-centre Contrast PMR study evaluating the use of contrast agents with its portable Swoop MRI system.

The prospective study is assessing whether contrast-enhanced ultra-low-field magnetic resonance imaging (MRI) can improve visualisation of brain lesions, particularly those associated with blood-brain barrier disruption, including brain tumours and inflammatory conditions.

The study uses gadolinium-based contrast agents and includes three separate measures of lesion appearance as endpoints. 

Hyperfine plans to use the findings to support an expanded indication for the Swoop system, with the company targeting submission of a 510(k) application to the US Food and Drug Administration (FDA) by the end of 2026 following image review and data analysis.

“We believe contrast-enhanced imaging can be a powerful catalyst for expanding adoption of the Swoop system and extending its value across the diverse care settings we serve,” said Maria Sainz, President and CEO, Hyperfine.

Sainz said the technology could support diagnostic and treatment decisions across a wider range of clinical settings, including outpatient care and post-procedural imaging in surgical environments.

The Swoop portable MRI system is FDA-cleared for brain imaging in patients of all ages and is designed to provide internal structural head images in settings where conventional diagnostic examinations may not be practical.

In July 2026, Hyperfine commercially launched its next-generation Swoop MRI system, Model 2, in select European markets.