Hyperfine Begins Commercial Launch of Optive AI™ Software, Bringing Substantially Improved Image Quality to the Installed Base of Swoop® Systems

Optive AI™ software has now been installed in an initial set of hospitals and neurology offices across the U.S., marking the beginning of expanded access to transformative, AI-powered image quality from portable, ultra-low-field MRI systems.

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 commercial launch of the Optive AI™ software for existing Swoop® system customers. Optive AI™ software, which also powers the transformative image quality of the next-generation Swoop® system, is now commercially available to customers in the U.S.

Optive AI™ software enhances each stage of the imaging process—from noise cancellation and image acquisition to reconstruction and post-processing. The result is brain images with greater clarity, uniformity, and sharper anatomical detail.

The FDA cleared Optive AI™ software in late May 2025, and the software is also available for commercial use in Canada, Australia, and New Zealand, with additional international approvals expected later this year. Hyperfine has now begun rolling out the new software to hospitals and outpatient neurology offices in the U.S. with plans to bring this imaging software to all current customers in the coming weeks.

Jennifer Villa Frabizzio, MD, Chief of Neuroradiology, Jefferson Abington Hospital, noted, "With over 650 scans under our belt on the previous software, with just a single scan in critical care today after installing Optive AI™ software on the Swoop® system, the difference is crystal clear. FLAIR images, especially, show markedly improved resolution and are 40 seconds faster. Kudos to Hyperfine engineers for this large leap."

Chetan Shah, MD, Chair, Pediatric Radiology, Wolfson Children's Hospital, noted, "This upgrade is a true game changer for MRI technology—an overnight leap in image quality that's rarely seen. Portable MRI can now extend beyond the ICU to serve ER patients and outpatients—a breakthrough in every sense."

Optive AI™ software is fully compatible with first-generation Swoop® systems and requires no hardware modifications, enabling current users to immediately benefit from next-generation image quality. The new software supports a wide range of patient populations, as well as various clinical use cases in emergency, intensive care, and neurology office settings.

"We're thrilled to bring the power of Optive AI™ software to our current customers," said Maria Sainz, President and CEO of Hyperfine. "This is more than a software update—it's a milestone that reflects our commitment to sustained innovation, improved clinical performance, and driving the adoption of portable brain MRI across multiple sites of care. We are incredibly pleased with the feedback from the initial cases of patients scanned with the Optive AI™ software and look forward to broadening clinical utility with this high level of image quality for patients in different care settings inside and outside of the hospital."

For more information about the Swoop® system and Optive AI™ software, 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

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. 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 impact of COVID-19 on the Company's business; the inability to maintain the listing of the Company's Class A common stock on the Nasdaq; 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 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; 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 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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