GUILFORD, Conn.--(BUSINESS WIRE)--Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced it has entered into a distribution agreement with Radiosurgery Global, Ltd. to develop the market in India. The distribution agreement also includes the countries of Malaysia, Indonesia, and Singapore through future expansion, offering Hyperfine, Inc. a significantly increased presence in Asia.

The clinical value of the Swoop® system is applicable globally as Hyperfine, Inc. aims to expand overall access and availability of MRI. In India, where there are fewer than 5,000 MRI scanners for a population exceeding 1.4 billion (approximately 3.5 MRI scanners per million inhabitants as compared to 38 per million in the U.S.), there is a growing need for specialized healthcare facilities and advanced diagnostic tools due to the increasing prevalence of chronic diseases like stroke and brain tumors. The current healthcare infrastructure, particularly in critical care and emergency settings, is under-equipped, with only fifteen percent of existing trauma centers having MRI capabilities. This gap highlights a substantial opportunity for introducing portable MR brain imaging systems that can meaningfully improve adult and pediatric care in urban and remote sites of care.

“Expanding commercially to Asia with a focus on India is an important element of our international strategy. We have begun preparing for the regulatory approval process through the CDSCO and are excited to partner with an experienced and capable group like Radiosurgery Global, Ltd. to drive commercial impact in 2025 and beyond,” said Maria Sainz, President and CEO of Hyperfine, Inc. “We believe that by expanding into global markets, we are not only revolutionizing healthcare delivery but also significantly impacting patient outcomes. We are committed to leveraging our expertise and partnerships to drive positive change in global brain health.”

“This partnership marks a significant crossroads for the entire region as we bring state-of-the-art portable MR brain imaging technology within reach of vast, underserved populations,” said Kapil Kalra, Managing Director of Radiosurgery Global, Ltd.

“The innovative Swoop® system aligns perfectly with our mission to democratize healthcare access in over 69,000 public and private hospitals across India, providing clinicians with unprecedented diagnostic imaging capabilities even in the most remote areas. We are excited about its enormous potential to enhance patient care nationwide,” said Timon Dressler, Managing Director of Radiosurgery Global, Ltd.

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.


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.