GUILFORD, Conn. – November 21, 2024 – 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 the issuance of new MRI standards by the Intersocietal Accreditation Commission (IAC), a leading CMS-approved accrediting body. The new standards, effective immediately, now include portable MR scanning at the point of care.
The IAC, a nonprofit accrediting organization dedicated to quality improvement and patient safety, has updated its advanced imaging standards to incorporate ultra-low-field MRI technology. The updated IAC Standards and Guidelines for MRI Accreditation addresses new technology that allows point-of-care service for MRI brain exams. This change enables IAC-accredited facilities and medical offices in the US to qualify for CMS reimbursement for brain scans performed using the Swoop® system.
The compact and versatile Swoop® Portable MR Imaging® system is designed for use in any professional healthcare setting, including medical offices. Its ultra-low field strength of 0.064T eliminates the need for costly shielded MRI rooms. Its plug-and-scan functionality and user-friendly tablet interface enable medical staff to easily operate the system.
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"The new IAC guidelines, which outline personnel, training, and safety requirements for MRI accreditation, pave the way for the Swoop® system to be available in neurology offices and clinics," said Maria Sainz, President and CEO of Hyperfine. "With IAC accreditation, physicians can now obtain diagnostic-quality MR brain images within their clinics, providing patients with timely and convenient MRI access at the point of care."
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 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 hyperfine.io.
