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Hyperfine receives FDA clearance for updated software to further improve diffusion-weighted imaging

Press releases may be edited for formatting or style | February 28, 2023 Business Affairs MRI
GUILFORD, CT – February 28, 2023 — Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking medical device company that created the Swoop® system, the world’s first FDA-cleared portable MRI system, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the latest update of its Swoop® system software. This updated software, which significantly improves diffusion-weighted imaging (DWI), highlights the company’s commitment to continuously improving image quality.

In this clearance, Hyperfine, Inc. achieved a significant 42% increase in the signal-to-noise ratio (SNR) for the DWI sequence compared to the previous software version. This increase in SNR, coupled with more robust compensation for subtle patient motion, yields substantially improved image quality for the DWI sequence. The updated software also provides enhanced image uniformity for all sequences.

The DWI sequence in MRI is important for patient care because it provides images that can be useful in diagnosing a wide range of neurological conditions, allowing for prompt and accurate treatment. The American Stroke Association guidelines recommend brain imaging be conducted 24 to 36 hours after ischemic stroke treatment1. For follow-up imaging of stroke patients, DWI imaging is crucial for monitoring stroke progression and evaluating the effectiveness of primary treatment, enabling healthcare professionals to make more informed decisions regarding ongoing patient care.
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“We are committed to continuously improving the provider and patient experience with the Swoop® system, with the goal of enabling more-confident patient diagnosis in the neurocritical care setting. With this latest software, Swoop® system images provide increasingly valuable diagnostic images that can aid clinicians in caring for neurocritical patients,” said Edmond Knopp, M.D., senior medical director of Hyperfine, Inc.

“We are ecstatic about the FDA clearance of our latest software,” stated Tom Teisseyre, the chief product officer of Hyperfine, Inc. “Our focus remains on enhancing the image quality of all sequences through better image acquisition and advanced AI-powered image reconstruction. I take immense pride in the considerable image quality that our team has achieved across the Swoop® system's T1, T2, FLAIR, and DWI sequences and delivering that to the point of care.”

About Hyperfine, Inc. and the Swoop® Portable MR Imaging® System
Hyperfine, Inc. (NASDAQ: HYPR) is the groundbreaking medical technology company that created the Swoop® system, the world’s first FDA-cleared portable magnetic resonance imaging (MRI) system capable of providing neuroimaging at the point of care. The Swoop® system received initial U.S. Food and Drug Administration (FDA) clearance in 2020 as a bedside 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 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 and Pakistan.

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