\nThe CDSCO approval authorizes the commercialization of the Swoop\u00ae portable MRI system throughout India. Hyperfine will distribute the Swoop\u00ae system in partnership with Radiosurgery Global, Ltd. (RSG), a leading medical device distributor with expertise in advanced medical imaging and an established network across India’s healthcare system.\n<\/p>\n
\n\u201cThe partnership between Hyperfine and RSG will enable us to transform a vision into reality. This partnership unites Hyperfine\u2019s transformative portable brain MRI technology with RSG\u2019s deep market access, regulatory fluency, and operational discipline in India,\u201d said Kapil Kalra, Managing Director, Radiosurgery Global, Ltd. \u201cThis collaboration addresses India\u2019s unmet need for accessible brain imaging while establishing a scalable pathway for sustained adoption of portable MRI throughout the healthcare system\u2014transforming how and where neurological imaging is delivered across the country.\u201d\n<\/p>\n
\nIndia represents one of the most significant global opportunities for improved access to neuroimaging. Despite a population exceeding 1.4 billion, the country has a comparatively limited base of MRI systems, with far fewer high-field scanners per capita than most developed nations. The high cost and complex infrastructure requirements of conventional MRI systems have historically prevented widespread adoption across India’s diverse healthcare landscape. Many patients\u2014particularly those in remote or lower-resource settings\u2014face long travel times to reach hospitals with MRI suites and prohibitive imaging costs, contributing to delayed diagnosis and limiting access to advanced neurological care.\n<\/p>\n
\n\u201cWith portability, low infrastructure requirements, and affordability relative to conventional MRI, the Swoop\u00ae system is particularly well-suited for India’s diverse healthcare landscape,\u201d said Maria Sainz, President and Chief Executive Officer of Hyperfine, Inc. \u201cFrom major urban hospitals to remote community health centers, the Swoop\u00ae system expands both geographic and economic access to brain imaging\u2014helping providers deliver timely assessment for conditions such as stroke, traumatic brain injury, and neurodegenerative conditions.\u201d\n<\/p>\n
\nShe continued, \u201cThis regulatory approval further advances our global expansion strategy and reinforces the value and opportunity of bringing brain imaging directly to patients worldwide.\u201d\n<\/p>\n
\nFor more information about the Swoop\u00ae system, please visit HyperfineMRI.com<\/a>.\n<\/p>\n About the Swoop\u00ae Portable MRI Systems<\/b><\/p>\n \nThe Swoop\u00ae Portable MR Imaging\u00ae 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.\n<\/p>\n About Hyperfine, Inc.<\/b><\/p>\n \nHyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop\u00ae system\u2014the 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\u00ae 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<\/a>.\n<\/p>\n \nThe 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.\n<\/p>\n Forward-Looking Statements<\/b><\/p>\n \nThis press release includes \u201cforward-looking statements\u201d within the meaning of the \u201csafe harbor\u201d provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the \u201cCompany\u201d) 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 \u201cexpect,\u201d \u201cestimate,\u201d \u201cproject,\u201d \u201cbudget,\u201d \u201cforecast,\u201d \u201canticipate,\u201d \u201cintend,\u201d \u201cplan,\u201d \u201cmay,\u201d \u201cwill,\u201d \u201ccould,\u201d \u201cshould,\u201d \u201cbelieves,\u201d \u201cpredicts,\u201d \u201cpotential,\u201d \u201ccontinue,\u201d 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\u2019s goals and commercial plans, the benefits of the Company\u2019s products and services, and the Company\u2019s 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\u2019s 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\u2019s product development and commercialization activities, including the degree that the Swoop\u00ae<\/i> system is accepted and used by healthcare professionals; the impact of COVID-19 on the Company\u2019s business; the inability to maintain the listing of the Company\u2019s Class A common stock on the Nasdaq; the Company\u2019s 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\u2019s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company\u2019s products and services and reimbursement for medical procedures conducted using the Company\u2019s products and services; the Company\u2019s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company\u2019s financial performance; and other risks and uncertainties indicated from time to time in Company\u2019s filings with the Securities and Exchange Commission, including those under \u201cRisk Factors\u201d 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.\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20251217651757\/en\/<\/a><\/span><\/p>\n Media Contact Investor Contact KEYWORDS:<\/b> Connecticut United States India North America Asia Pacific<\/p>\n INDUSTRY KEYWORDS:<\/b> Neurology Radiology Health FDA Artificial Intelligence Medical Devices Health Technology Technology<\/p>\n<\/p>\n
\n
<\/b>Devin Zell
\n
Hyperfine
\n
dzell@hyperfine.io<\/a><\/p>\n
\n
<\/b>Webb Campbell
\n
Gilmartin Group LLC
\n
webb@gilmartinir.com<\/a><\/p>\n
![\"Logo\"](\"https:\/\/mms.businesswire.com\/media\/20251217651757\/en\/2375273\/3\/Hyperfine_Logomark_Full_Color_RGB_600px_tall.jpg\")
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