Hyperfine Shares Data Demonstrating Value of Swoop System for Acute Stroke Care

Hyperfine Inc. is sharing positive interim data about the role portable ultra-low-field magnetic resonance imaging (MRI) can play in acute stroke workup in a hospital emergency department setting.

The study, titled “Interim Analysis from Single Centre Observational Study of Ultra-Low Field Portable MRI in Acute Stroke Diagnostic Workup,” included a subset of patients from the first phase of the prospective, international, multi-site ACTION PMR (Acute Ischemic Stroke Detection with Portable MR) trial. The study analyzed images from Hyperfine’s portable magnetic resonance (MR) brain imaging solution (Swoop system) to assess its 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 computed tomography.
 
Key findings showed 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.”
 
The Swoop Portable MR Imaging system is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device 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. The Swoop system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop system is commercially available in a select number of international markets.
 
Hyperfine Inc.’s Swoop system is capable of providing imaging at multiple points of professional care. The company aims 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 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.