Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop system—today announced the presentation of interim data supporting the role portable ultra-low-field MRI can play in acute stroke workup in a hospital emergency department setting.
The findings from the study, titled Interim Analysis from Single Centre Observational Study of Ultra-Low Field Portable MRI in Acute Stroke Diagnostic Workup, were presented by Keith Muir, MD, of the University of Glasgow, during a scientific session at the 2024 European Society of Neuroradiology (ESNR) Annual Meeting.
This study, which includes a subset of patients from phase one of the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) study, analyzed images from the ultra-low-field Swoop MR brain imaging system to assess the system’s performance in acute care stroke workup as compared to the current standard of care. The analysis compared time-to-scan, diagnostic performance, specificity, and patient experience between ultra-low-field MRI, conventional MRI, and head CT.
Key findings showed that the Swoop system was dramatically faster than conventional MRI, with a median time-to-scan of 2.5 hours compared to 27.7 hours. The data also demonstrated reliability in acute stroke diagnosis with comparable diagnostic performance compared to head CT and good specificity when compared to routine clinical MRI (1.5T). Further, nearly all patients reported a positive experience with the Swoop system.
The conclusion states, “This interim analysis demonstrates that the portable [ultra-low-field] MRI system is a promising tool for the acute stroke diagnostic workup in an emergency department setting. The improved time to imaging compared to routine MRI could facilitate quicker decision-making in acute stroke management. Additionally, the high tolerance rate among patients underscores its potential usability in a clinical environment. The findings suggest that portable [ultra-low-field] MRI could enhance stroke diagnosis accessibility and efficiency, particularly in settings where conventional MRI availability is limited.”
Dr. Edmond Knopp, Vice President of Medical Affairs at Hyperfine, commented, “Being at ESNR in Paris this year and showcasing our Swoop system, we witnessed the growing interest and enthusiasm across the European neuroradiology community. This excitement was most notable when the attendees had the opportunity to see the system up close and personal. We were very pleased with Dr. Muir and his team’s participation in the ACTION PMR stroke study, and it was great to have Dr. Muir share exceptional data acquired during the study. Their findings highlight the potential of the Swoop system’s clinical impact in improving stroke diagnosis and treatment.”
