Following the recent clearance of the new Swoop® System, two leading hospitals in the United States have purchased the first commercial units, marking the launch of next-generation portable MR brain imaging.
GUILFORD, Conn.--(BUSINESS WIRE)--Jul. 17, 2025--
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—announced today the first commercial sales of the next-generation Swoop® system powered by proprietary Optive AI™ software. Both of these pioneering hospitals plan to utilize the technology in intensive care units and emergency department settings.
The initial sales of the next-generation Swoop® system—purchased by two top-tier hospitals in the northeastern United States—demonstrate a strong market response following FDA clearance and mark a critical step toward the widespread clinical adoption of portable brain imaging with diagnostic-level clarity.
“This marks the start of a new phase for Hyperfine—one where our vision to transform MRI access is driven by a new system that is commercially ready, is clinically valuable, has outstanding image quality and functionality, and is garnering strong customer interest,” commented Maria Sainz, President and CEO of Hyperfine. “Attaining the milestone of first commercial sales and deliveries of the new Swoop® system just weeks after FDA clearance is the result of seamless execution across the organization—from industry-leading product development to accelerated clearance to rapid manufacturing ramp to initial sales. We are excited about the momentum with the new Swoop® system and the growth we anticipate in the second half of 2025 and beyond.”
The new Swoop® system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI™ software, achieve exceptional image quality, including improved resolution, uniformity, and faster acquisition times. This new level of image quality has the potential to dramatically drive the adoption of the Swoop® system across sites of care and multiple clinical applications. The new Swoop® system also delivers a user and patient-centric design to accommodate a broad patient population—especially beneficial for pediatric, elderly, or anxious patients—making MRI more accessible for all.
For more information about the Swoop® Portable MR Imaging® system, please visit HyperfineMRI.com.
About the Swoop® AI-Powered Portable MRI (V2) System
The Swoop® Portable MR Imaging® (V2) System is U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. It is a portable, ultra-low-field magnetic resonance imaging device 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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Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Source: Hyperfine, Inc.
