Hyperfine has initiated the launch of the next-generation Swoop® system in European markets, beginning the global expansion of its most advanced portable MRI technology.

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 the European launch of the next-generation Swoop® system powered by the latest advancement in Optive AI™ software. This marks a significant milestone in the company’s global expansion of its most advanced portable MRI technology, supporting international commercial growth and improving global access to high-quality brain imaging at the point of care.

Following CE mark and UKCA approval, the next-generation Swoop® system, also known as Model 2, is now commercially available across an initial wave of European markets.

Professor Steve Williams, Professor of Neuroimaging at King’s College London and Head of the Department of Neuroimaging at the Institute of Psychiatry, Psychology & Neuroscience, commented, "I've been involved with Hyperfine since the earliest days of portable MRI, and the relentless progress has been remarkable. With the next-generation Swoop® system, the improvement in image quality is transformative. Having spent my career exploring advanced brain imaging, I am impressed that low-field MRI can provide this level of diagnostic-quality images. For years, limited access to neuroimaging has delayed diagnosis and treatment for countless patients around the world. The Swoop® system is uniquely positioned to address that gap, making MRI accessible when and where it is needed, even in remote locations, to support decision-making in a wider range of care settings across the lifespan."

Hyperfine also announced the inclusion of its next-generation Swoop® system (Model 2) in the UniHA procurement listing, a key milestone enabling broader adoption across hospitals within the French public healthcare system. The initial inclusion of the Swoop® system in this listing was in October 2025.

"We are proud to bring Hyperfine’s most advanced portable MRI technology to clinicians across Europe and the UK, delivering on an important milestone for our commercialization strategy in 2026," said Eric Willis, Vice President of International at Hyperfine. "The next-generation system delivers significant improvements in image quality, workflow efficiency, and clinical capability. We have already seen these advancements accelerate use and adoption of the Swoop® system throughout the United States. We look forward to working closely with our distribution partners to expand access to AI-powered portable MRI across Europe, providing critical neuroimaging that helps clinicians make more timely and more informed patient care decisions. By the end of the year, we plan to make the Model 2 Swoop® system available through our distribution partners across all European markets where Hyperfine is represented."

The European commercial launch adds to Hyperfine’s recent corporate momentum, including its inclusion in the Russell 2000® Index, as the company continues to expand global access to its AI-powered portable MRI technology.

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.

Forward-Looking Statements

This press release includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the "Company") may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future ; the inability of the Company to progress on product advancements and improvements ; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under "Risk Factors" therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

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Media Contact

Devin Zell

Hyperfine

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Gilmartin Group LLC

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