The expansion into global markets is supported by the company’s strong track record of securing international approvals for the Swoop® system. In 2023, Hyperfine, Inc. obtained CE certification under the EU MDR and UKCA certification in the United Kingdom for its latest hardware and eighth-generation AI-powered software. In May of 2024, the company announced the appointment of distributors in France, the United Kingdom, and Italy. Hyperfine, Inc. plans to continue its commercial expansion in partnership with Radiosurgery Global, Ltd. supporting future marketing submissions in India.
The system the company is introducing to the European and Indian markets is commercialized in the U.S. and uses the highest performing Swoop® system software to date in terms of image quality and usability. Introducing the Swoop® system into international markets is a significant step in supporting the commercial growth of Hyperfine, Inc. The Swoop® system could expand the existing imaging market with its transformative, affordable, and accessible platform to serve more clinicians and patients needing brain imaging. The versatility of the Swoop® system across multiple sites of care offers a solution to patients in varied settings who may not have access to the latest MRI technologies.
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About the Swoop® Portable MR Imaging® System
The Swoop® Portable MR Imaging® 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. The Swoop® system also has CE certification in the European Union and UKCA certification in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.
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 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 hyperfine.io.
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