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 treatmenti. 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.
“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.”
The updated Swoop® system software is expected to roll out to customers in March 2023.
For more information about the Swoop® Portable MR Imaging® System, please visit hyperfine.io.
