Latest Optive AI™ software receives CE mark and UKCA approvals, supporting the ongoing Swoop system Model 2 rollout, already underway in four international markets; “Notes and Neurons” showcases portable brain imaging in a German music and brain-health awareness series.

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 CE mark and UKCA approval for its latest Optive AI™ software update in Europe, further enhancing the capabilities of the Swoop system and supporting broader adoption across medical and emerging brain health applications.

The latest Optive AI software builds on the advances introduced with Model 2, further improving image quality across Swoop system sequences with enhanced noise correction while providing a more intuitive scanning experience with guided workflow. The software also includes a new isotropic T1 sequence that delivers thinner slices and uniform high resolution across imaging planes, which will strengthen the clinical utility of the Swoop system, particularly in surgical and clinic settings.

The latest technology advancement builds on early commercial progress since Hyperfine's mid-2026 launch of the Swoop system Model 2 in Europe. Within months of launch, Hyperfine has achieved Model 2 sales across four international markets, with flagship institutions in the UK, France, and Romania, among other markets, already using the next-generation Swoop system. “The European approval of Model 2 was an important milestone in Hyperfine's international growth strategy and early adoption in key European markets demonstrates progress in the company's international commercialization plan,” said Eric Willis, Vice President of International at Hyperfine.

As we enter into the decade of brain health, Hyperfine is positioned to expand the use of the Swoop system beyond traditional medical applications into the emerging field of brain health. To help advance this effort, Hyperfine is supporting Notes and Neurons: Music for Brain Health, a nationwide German initiative that brings together musicians, neuroscientists, clinicians, and the public to explore how music affects memory, emotion, and brain function. The program features six symphonic performances that combine live music, scientific education, audience participation, and brain imaging with the Swoop system. The Swoop system is being showcased through live, on-stage scanning of select musicians during the performances. Led by organizations including University Hospital Bonn, University of Bonn, Max Planck Institute for Empirical Aesthetics, and the German Center for Neurodegenerative Diseases (DZNE), the initiative aims to advance research while increasing public awareness of the connection between music and brain health, particularly in dementia prevention.

“We have a long-standing relationship with researchers at the University of Bonn and are proud to support them in this innovative program by enabling them to bring brain imaging directly into the concert environment,” said Maria Sainz, Chief Executive Officer of Hyperfine. “Programs like Notes and Neurons highlight how portable MRI can help study the brain in entirely new settings while making brain health more accessible to the public. We are also seeing increasing commercial interest in the potential role of the Swoop system in brain health applications worldwide, representing an exciting opportunity for future growth.”

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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The European approval of Model 2 was an important milestone in Hyperfine's international growth strategy and early adoption in key European markets demonstrates progress in the company's international commercialization plan.