Hyperfine Receives FDA Approval for AI-powered Software That Improves Image Quality

Hyperfine the groundbreaking medical device company that has redefined brain imaging with the world’s first FDA-cleared portable magnetic resonance brain imaging system—the Swoop system announced FDA clearance of updated software. Built on a robust AI foundation, the latest software brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence.

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With this latest software update, Hyperfine, Inc. expands the Swoop system’s AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. The system’s other sequences (T1, T2, and FLAIR) previously benefited from this AI feature. Denoising enables a crisper image that potentially helps clinicians more accurately diagnose, treat, and monitor patients undergoing brain imaging.

“We believe in making brain imaging more accessible, clinically relevant, and actionable. We continue to make meaningful progress across all sequences. With this significant and most recent update, we now incorporate deep learning into our DWI sequence,” said Tom Teisseyre, chief operating officer of Hyperfine, Inc. “These imaging improvements will serve a critical role in enhancing image quality for healthcare professionals in time-sensitive environments.”

Maria Sainz, president and CEO of Hyperfine, Inc., remarked, “Our eighth FDA software clearance in three years for the Swoop® system underscores our relentless drive for innovation and continuous improvement. Our focus remains on providing quality brain imaging to more providers and patients in more sites of care. More than milestones, it’s about reshaping patient care, empowering clinicians, and advancing brain imaging.

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Hyperfine is the groundbreaking medical technology company that has redefined brain imaging with the Swoop system—the world’s first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care. The Swoop system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a portable magnetic resonance brain imaging device for producing images that display the internal structure of the head where a 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 has been approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, CE certification in the European Union, and is also available in New Zealand.

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