Prospective randomized ED study shows rapid bedside imaging, detection of critical neurological findings, and potential workflow efficiency benefits with portable MRI

Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the presentation of results of the PRIME (Portable Rapid Imaging for Medical Emergencies) study at the Society for Academic Emergency Medicine (SAEM) 2026 Annual Meeting.

PRIME is a single-center, prospective, randomized controlled trial designed to evaluate the role of portable MRI in neurological emergencies in the emergency department (ED), including the technology’s potential effectiveness and efficiency in supporting triage decisions for a wide range of brain-related emergency medical conditions. Conducted at a tertiary emergency department, the study enrolled 100 participants and compared standard clinical workflow using conventional MRI, along with a care pathway that incorporated a portable MRI system at the patient’s bedside.

Results presented at SAEM demonstrate a significant reduction in time to imaging for patients randomized to the portable MRI arm. Median time from imaging order to scan start was 1.28 hours in the portable MRI group, compared with 7.76 hours in the conventional MRI only control arm—a median difference of 6.35 hours. 18.6% of the scans completed revealed critical pathology, including acute ischemic stroke, mass lesions, mass effect, and hydrocephalus, all of which were successfully detected by portable MRI and confirmed on conventional MRI.

“These findings suggest that portable MRI can be integrated into emergency department workflow far more quickly than conventional MRI and can provide clinically meaningful information when time matters most,” said Dr. Charles Wira, Associate Professor of Emergency Medicine at Yale University. “By bringing advanced imaging to the bedside, portable MRI has the potential to improve diagnostic efficiency, reduce delays, and support faster treatment decisions for patients with neurological emergencies.”

“Portable MRI also has the potential to meaningfully reduce emergency department boarding by helping to alleviate delays associated with waiting for access to conventional MRI,” said Dr. Kevin Sheth, Professor of Neurology and Neurosurgery at the Yale School of Medicine and principal investigator for the PRIME study. “Reducing imaging-related bottlenecks may help ED teams move patients through care pathways more efficiently while maintaining access to advanced neuroimaging.”

The PRIME study builds on prior research evaluating portable MRI in emergency settings and expands the evidence base by studying a broader emergency department population. PRIME was conducted using the Hyperfine Model 2 Swoop® portable MRI system powered by Optive AI™ software, which is designed to deliver sharper anatomical detail and support broader use of portable brain imaging across emergency care environments.

“Enrollment in PRIME was very fast, signaling how frequently MRI is needed as a triage tool in the ED. The presentation of these data at SAEM represents an important milestone for Hyperfine and for the future of emergency neuroimaging,” said Maria Sainz, President and CEO of Hyperfine. “We believe these results reinforce the potential for portable MRI to help clinicians access actionable imaging information sooner, improve emergency department workflows for ruling in and ruling out pathology, and expand access to advanced brain imaging where conventional MRI remains difficult to obtain.”

Hyperfine is committed to advancing the role of portable MRI in emergency care, where timely access to conventional MRI remains a challenge for many hospitals. The PRIME study adds to a growing body of evidence supporting portable MRI as an efficient adjunct to emergency neuroimaging and underscores its potential to reduce diagnostic delays and improve patient care at the point of care.

For more information about the Swoop® system, please visit HyperfineMRI.com.

About the Swoop® AI-Powered Portable MRI Systems

The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

About Hyperfine, Inc.

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com.

Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine.

Forward-Looking Statements

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These findings suggest that portable MRI can be integrated into emergency department workflow far more quickly than conventional MRI and can provide clinically meaningful information when time matters most.