Hyperfine, Inc. completed enrollment of the Contrast PMR study, a prospective, multi-center clinical study evaluating contrast-enhanced ultra-low-field portable MRI using its Swoop system, supporting the first expansion of the device's indications since its original FDA clearance.

Contrast-enhanced MRI plays a critical role in evaluating brain tumors, inflammatory disorders, and other conditions associated with blood-brain barrier disruption, representing a meaningful portion of brain MRI examinations performed today. The study evaluates the Swoop system's ability to visualize common contrast-enhancing brain lesions using gadolinium-based contrast agents across three endpoints related to lesion appearance.

W. Taylor Kimberly, MD, PhD, Chief, Division of Neurocritical Care, Neurology, Mass General Brigham, said, "The completion of enrollment of the Contrast PMR study is an important milestone in expanding the use of portable MRI across clinically relevant imaging modalities across a broader range of neurological applications. Contrast-enhanced imaging is fundamental to the evaluation of many brain lesions, including tumors and other conditions associated with blood-brain barrier disruption. This study is designed to assess whether portable MRI can provide meaningful visualization of the types of lesions neurologists and neurosurgeons routinely evaluate using contrast-enhanced MRI."

Hyperfine, based in Guilford, Connecticut, is a health technology company that developed the first FDA-cleared AI-powered portable MRI system for the brain.

"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 Chief Executive Officer of Hyperfine. "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."

Following completion of enrollment, Hyperfine will proceed with image review, data analysis, and preparation of a planned FDA 510(k) submission by the end of 2026.