Hyperfine AI Software Gets FDA Green Light for Clearer MRIs

Hyperfine's latest Swoop System software is set to deliver a substantial leap in image quality for AI-powered portable MR brain imaging, following a key regulatory approval.

Advancing Brain Imaging Optive AI Receives FDA Clearance

Hyperfine, Inc. (HYPR), recognized for redefining brain imaging with the world's first FDA-cleared AI-powered portable MRI system for the brain—the Swoop system—has announced FDA clearance for its next-generation software. This tenth-generation release, known as Optive AI software, represents a significant advancement in image quality for ultra-low-field MR imaging.

How Optive AI Enhances Image Quality

Optive AI software improves each stage of the imaging process, including noise cancellation, image acquisition, reconstruction, and post-processing. The outcome is brain images with greater clarity, uniformity, and sharper anatomical detail. These advanced AI algorithms are applied across all imaging sequences of the Swoop system.

Positive Early Clinical Feedback

Earlier this year, Hyperfine released the software at select clinical sites. Early users responded enthusiastically to the image quality improvements, with some reporting that the image quality is approaching that of conventional 1.5 tesla MRI scanners. This feedback highlights the clarity and consistency of the new images, which can enhance patient care.

A Transformative Era for Hyperfine

Rafael O’Halloran, Hyperfine Vice President of Technology, stated, “This software release marks the beginning of a transformative era for Hyperfine. The advanced AI algorithms integrated into our new software platform dramatically elevate image quality at ultra-low field strength, enabling more confident diagnoses at the point of care. We previewed Optive AI software at the recent American Society of Neuroradiology annual meeting and received outstanding feedback. It’s the strongest signal yet of where we’re headed—and how far AI-powered portable MRI imaging can go.”

Strategic Milestone and Future Growth

Tom Teisseyre, Hyperfine Chief Operating Officer, commented, “Optive AI software is our tenth software release since initial FDA clearance and marks a critical inflection point in the evolution of Swoop system technology—the first of two major technology milestones we have been looking forward to this year. The significant image quality enhancements enabled by Optive AI software will serve as a catalyst for our 2025 growth strategy, supporting expansion into new hospital sites of care and our entry into the neurology office market.”

Availability

Hyperfine plans to initiate the rollout of Optive AI software to accounts in the third quarter of 2025.

For more information about the Swoop AI-powered portable MRI system, please visit hyperfine.io.

Understanding 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 is also CE marked in the European Union and is UKCA marked in the United Kingdom. The Swoop system is commercially available in a select number of international markets.

About Hyperfine Inc

Hyperfine, Inc. (HYPR) is a health technology company that has redefined brain imaging with the Swoop system—the first FDA-cleared, AI-powered, 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.

Important Considerations Regarding Forward Looking Statements

This information includes “forward-looking statements” as defined by the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results for Hyperfine, Inc. may differ from its expectations and projections. Therefore, these forward-looking statements should not be relied upon as predictions of future events. These statements cover Hyperfine’s goals, commercial plans, product benefits, future performance, and strategy implementation. They involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Many of these factors are outside Hyperfine’s control and are difficult to predict. Factors include product development success, cost, and timing; market acceptance of the Swoop system; COVID-19 impact; stock listing maintenance; growth management; regulatory changes; financing ability; obtaining and maintaining regulatory clearance; technology acquisition; supply chain management; competition; market size and growth; product pricing and reimbursement; and financial performance. Other risks are detailed in Hyperfine’s SEC filings. Hyperfine does not undertake updates or revisions to any forward-looking statements.