Hyperfine Announces FDA Clearance of the Next Optive AI™ Software, Further Enhancing Image Quality, Clinical Utility, and Ease of Use of the Swoop® System Across Care Settings

This newest software delivers improved image quality across Swoop system sequences, a more intuitive scanning experience, and new foundational isotropic imaging designed to strengthen the clinical utility of portable MRI.

GUILFORD, Conn., Aug 20, 2026, ZEX PR WIRE — 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 that it has received FDA clearance for its latest Optive AI™ software update. This advancement is Hyperfine’s second FDA-cleared software package since the launch of its next-generation Swoop system in mid-2025. It builds on Hyperfine’s Optive AI software to deliver even higher image quality in challenging clinical environments, a more intuitive scanning experience for Swoop system operators, and a new imaging sequence for three-dimensional visualization—further extending the clinical value of the Swoop system across care settings.

Since the Swoop system does not require the shielding that conventional high-field MRI systems depend on, it can scan in electromagnetically noisy environments, such as intensive care units and emergency departments, without sacrificing image quality. This latest advancement in Optive AI software takes Hyperfine’s proprietary noise cancellation a step further, improving noise correction across all sequences to deliver clearer, more consistent images that move closer to high-field quality, even in noisy point-of-care environments where only the Swoop system can go. The software also introduces an improved user interface with a more guided scanning workflow and lets operators view sequences and images as they’re being acquired, making the system even more intuitive and easier to use.

This latest update debuts the isotropic T1 sequence, delivering thinner slices and equally high resolution across all imaging planes. This new capability is especially valuable in clinical situations where spatial visualization supports clinical assessment, such as post-operative tumor follow-up, and represents a new brain imaging capability now possible in the ultra-low field Swoop system.

“This latest advancement reflects our commitment to frequent Optive AI software updates that continuously expand the clinical value of the Swoop system and provide our customers with access to the most advanced portable brain MRI technology available,” said Tom Teisseyre, Chief Operating Officer of Hyperfine. “This software is designed to improve performance today and is also architected for our ultra-low-field future. Capabilities such as the new isotropic T1 sequence are particularly exciting because they demonstrate just how clinically valuable imaging at this field strength can be. We’ve also established a foundation for future potential applications such as neurosurgery contrast imaging and quantitative MRI, opening the door to additional sites of care for the Swoop system.”

Hyperfine plans to start the rollout of this new software in the United States to existing and new Swoop system users in September.

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.

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