Hyperfine Demonstrates World’s First FDA-Cleared, Portable, Ultra-Low-Field, MR Brain Imaging System

The Swoop system which is capable of providing imaging at multiple points of care received initial U.S. Food and Drug Administration (FDA) clearance in 2020. It is a portable ultra-low-field MRI device for producing images that display the internal structure of the head where a 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. Traditionally, access to costly, stationary, conventional MRI technology can be inconvenient or not available when needed most. With the portable, ultra-low-field Swoop system, Hyperfine, Inc. is redefining the neuroimaging workflow by bringing brain imaging to the patient’s bedside.

In addition, Hyperfine is presenting three scientific sessions highlighting ultra-low-field imaging data at RSNA 2023. These studies analyzed how portable MR brain imaging may assist physicians in the diagnosis and management of neurological conditions in critical care settings. The first session titled ‘Longitudinal Relaxivity Estimation of Gadolinium-based Contrast Agents’ is being presented by Sudarshan Ragunathan, Ph.D., and the second session titled ‘A Generative Adversarial Network Approach for Low-field to High-field Image Translation’ is being presented by Alfredo Lucas. The third session titled ‘Point-of-care Brain MRI: Update on Preliminary Results from a Single-center Retrospective Study in the Neurocritical Care Setting’ is being presented by Brian Gerard Yep, MD.

“At Hyperfine, Inc., we strive to push the boundaries of medical technology to make MR brain imaging more accessible, and our presence at RSNA 2023 underscores the promise of expanded use cases for portable MR brain imaging technology,” said Chip Truwit, MD, Hyperfine, Inc. vice president of scientific affairs. “We’ll continue to prioritize clinical application research for the Swoop system because expanding access to portable MR brain imaging is critical in improving how patient care is delivered.”

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