The largest dataset to date on stroke detection with the Swoop® system demonstrates the ability to identify small strokes rapidly and reliably, reinforcing its clinical value for acute care and emergency settings.

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 results from the largest data set to date evaluating stroke detection with the Swoop® system. This data provides strong evidence supporting the use of AI-powered portable MRI for stroke detection in multiple clinical settings, including the emergency department.

The prospective multi-center observational study, published in the November issue of Stroke: Vascular and Interventional Neurology (SVIN), evaluates 95 patients, combining data from the ACTION PMR study at Massachusetts General Hospital and Buffalo General Medical Center, with data from Yale New Haven Hospital. The study evaluated the sensitivity and specificity of ischemic lesion detection, comparing both the original and next-generation Swoop® system scanners, along with a comparison of two types of DWI sequences, a sequence that is critical for stroke detection.

The advanced multi-directional DWI sequence on the next-generation Swoop® system achieved dramatic improvements in diagnostic performance over the original scanner:

• Enhanced Detection of Small Lesions: Successfully identified lesions as small as 2.8 mm (0.15 mL), enabling detection of very small strokes
• Perfect Accuracy for Clinically Relevant Lesions: Achieved 100% sensitivity and 100% specificity for lesions greater than 1.0 mL.
• Improved Efficiency: Reduced scan time by approximately 30%, making stroke imaging feasible in time-critical emergency settings
• Superior Image Quality: Demonstrated improved image uniformity across the brain, enhancing diagnostic confidence

“We previously showed that using DWI in combination with FLAIR on the portable MRI system can be used as a 'tissue clock' for stroke detection, similar to conventional MRI. With this study, we took the next step and evaluated the capability of ultra-low-field MRI with advanced, multi-directional DWI sequences to detect very small ischemic lesions,” said Taylor Kimberly, MD, PhD, Chief of the Neurocritical Care Division at Mass General Brigham. “The results show that the next-generation portable MRI system with a multi-directional DWI sequence enables detection of very small strokes in a clinically feasible timeframe. The portable MRI system’s ability to detect clinically relevant strokes opens new possibilities for transforming stroke diagnosis and management—bringing timely evaluation to more patients and care settings than ever before.”

"Stroke detection represents a critical driver of the Swoop® system's expansion into emergency departments,” commented Maria Sainz, President and CEO of Hyperfine. “The results from our next-generation Swoop® system, combined with our new, advanced multi-direction DWI sequence that was recently cleared by the FDA, are truly remarkable. This data gives us even greater confidence that the Swoop® system can reliably detect clinically relevant strokes, streamline workflows, and further strengthen the value of integrating portable MRI into stroke diagnosis and care.”

Hyperfine provided portable MRI systems as part of sponsored research agreements. The company was not involved in the design or analysis of this investigator-initiated study, nor in the publication decision.

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

About the Swoop® 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.

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

Forward-Looking Statements

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Stroke detection represents a critical driver of the Swoop® system's expansion into emergency departments.