Hyperfine has completed patient enrolment in its multi-centre Contrast PMR study examining the use of contrast agents with the company’s portable Swoop MRI system.
The prospective study will investigate whether contrast-enhanced, ultra-low-field magnetic resonance imaging (MRI) using Swoop can improve lesion visualisation in the brain.
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Hyperfine plans to use the study data to support its first expanded indication submission for the Swoop system since initial FDA clearance, with a 510(k) application targeted for submission by the end of this year following image review and data analysis.
The study specifically focuses on the Swoop system’s ability to visualise lesions associated with blood-brain barrier disruption, such as those seen in brain tumours and inflammatory conditions, using gadolinium-based contrast agents.
The study’s endpoints involve three separate measures of lesion appearance.
Hyperfine president and CEO Maria Sainz said: “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.
“In addition to supporting critical diagnostic and treatment decisions across a broad range of clinical settings, contrast-enhanced brain imaging benefits from established dedicated reimbursement pathways, creating a strong foundation for adoption and long-term value for providers.
“We see this unlocking expanded use in outpatient settings and opening new applications for post-procedural imaging in surgical environments, including assessment of residual tumour after resection.”
The Swoop portable MRI systems have FDA clearance for brain imaging in patients of all ages and provide internal structural head images in situations where standard diagnostic examinations are not practical.
In July, Hyperfine commercially launched its next-generation Swoop MRI system (Model 2) in select European markets.
