New Yale Study Shows Portable MRI Cuts Time to Brain Imaging by 80% in the Emergency Department

The PRIME (Portable Rapid Imaging for Medical Emergencies) study suggests portable MRI can enable earlier diagnostic decision-making, reducing imaging bottlenecks to improve patient outcomes. Yale New Haven Health’s ED reported consequential differences in the median time from imaging order to scan start between the two groups. Patients in the portable MRI cohort began scanning a median of 6.35 hours before those in the conventional MRI-only cohort.

Lioness MedTech AB and Hyperfine, Inc. (Nasdaq: HYPR) announce the results from the PRIME (Portable Rapid Imaging for Medical Emergencies) study. Emergency department settings report that portable MRI slashes the time from brain imaging order to scan start from the length of a transatlantic flight to the length of a lunch. This study is of high relevance to the Nordic region, where Lioness Medtech AB serves as the agent and distributor of the Swoop® Portable MR Imaging® System from Hyperfine Inc. The Swoop® Portable MR Imaging® System is CE-marked and compliant with EU medical device regulations.

Results from the single-center, prospective, randomized controlled trial were first presented at the Society for Academic Emergency Medicine (SAEM) Annual Meeting in Atlanta, GA, USA. The PRIME study evaluated the real-world implementation of the Swoop® Portable MR Imaging® System, the world’s first FDA-cleared and CE-marked AI-powered portable MRI system for the brain, and was conducted at the Yale New Haven Health Emergency Department (ED), a Level 1 ED.

Study Design and Key Findings

The randomized controlled study was focused on measuring the median time from brain imaging order to scan start across 100 participants in the adult ED over a 7-month period. The study builds on the earlier ACTION PMR: Acute Ischemic Stroke Detection with Portable MR study, broadening the scope to a wider range of brain-related emergency conditions including hydrocephalus, mass lesions, and mass effect. Imaging was performed using the next-generation Swoop® Portable MR Imaging® system powered by the latest advancement in Optive AI™ software. Patients were randomized to receive either the standard of care (traditional MRI alone) or portable MRI followed by the standard of care, with all participants receiving conventional MR imaging regardless of group assignment.

Swoop® Portable MR Imaging® System in Transport

Yale New Haven Health’s ED reported consequential differences in the median time from imaging order to scan start between the two groups. Patients in the portable MRI cohort began scanning a median of 6.35 hours before those in the conventional MRI-only cohort, with a median of 1.28 hours in the portable MRI group compared to a median of 7.76 hours in the conventional MRI-only group. This window can be clinically significant for patients with acute ischemic stroke, where earlier confirmation can mean the difference between qualifying for first-line treatment with thrombolytics, also known as “clot-busting” drugs. Receiving first-line treatment significantly improves the odds of a full, disability-free recovery. Every hour of delay in confirming a stroke and starting treatment costs measurable brain tissue and correlates with worse functional outcomes. Importantly, all critical pathology identified on portable MRI was consistent with conventional MRI. Taken together, the PRIME results suggest portable MRI can enable earlier diagnostic decision-making, reducing imaging bottlenecks to improve patient outcomes.

Clinical Impact and Strategic Implications for Hospitals

Physicians at Yale University praised the clinical potential of the Swoop® Portable MR Imaging® System. “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 Associate Professor of Emergency Medicine, Dr. Charles Wira. “Portable MRI has the potential to improve diagnostic efficiency, reduce delays, and support faster treatment decisions for patients with neurological emergencies.” Professor of Neurology and Neurosurgery, Dr. Kevin Seth, noted its ability “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.”

Swoop® Portable MR Imaging® System Tablet View

As emergency departments continue to face pressure from patient boarding and severe staff shortages, the PRIME results add to a growing body of evidence supporting portable MRI as a valuable asset in time-sensitive emergency care settings. That urgency was reflected in how quickly the study was able to enroll participants. Maria Sainz, President and CEO of Hyperfine, noted, “Enrollment in PRIME was very fast, signaling how frequently MRI is needed as a triage tool in the ED.”

Swoop® Portable MR Imaging® System in the Emergency Department

Watch the Swoop® Portable MR Imaging® System in action here!

The full Hyperfine press release is available at: https://investors.hyperfine.io/news-releases/news-release-details/hyperfine-announces-presentation-results-prime-study-showing

Study details are available on ClinicalTrials.gov under study ID NCT06930534: https://clinicaltrials.gov/study/NCT06930534?id=NCT06930534&viewType=Card&rank=1

Disclaimer: This press release contains forward-looking statements that involve risks and uncertainties and may differ materially from actual results. These statements reflect current expectations regarding the Company’s strategy, products, and future performance. Factors that could cause differences are described in the Company’s filings with the U.S. Securities and Exchange Commission. Hyperfine undertakes no obligation to update these statements except as required by law.

About Lioness Medtech AB

Lioness Medtech AB is a European medical technology integrator and value-added reseller (VAR) for leading innovations in medical imaging and therapy. Lioness represents and services world-leading solutions across medical imaging, radiotherapy, and quality assurance in the Nordic region and select European markets. www.lionessmedtech.com

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Bernt Nordin

Managing Director

Lioness Medtech AB (publ)

Email: bernt.nordin@lionessmedtech.com

Tel: +46 70 996 0445