Hyperfine’s Upgraded AI-Powered Software Cleared by FDA

Hyperfine Inc., the medical device company that created the Swoop system, an FDA-cleared portable magnetic resonance imaging (MRI) device for imaging of the brain, has announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and launch of its upgraded AI-powered software.
 
The most recently cleared Swoop software improves the image quality of the diffusion-weighting imaging (DWI) sequence with increases in its signal-to-noise ratio. An additional update in this software release increases the Swoop Portable MR Imaging System field of view by 10% for T1, T2, and FLAIR sequences to match the previously improved DWI sequence’s 20cm field of view. Field of view size is important for visualizing pathology deep in the brain.
 
“The latest Swoop software improves image quality with notable improvement in the appearance of the DWI images. The improved image quality more clearly displays underlying brain structure, further accentuating diffusion positivity and potentially increasing confidence in image interpretation and clinical decision-making,” said Edmond Knopp, M.D., senior medical director of Hyperfine Inc.
 
“Our team continues to make rapid and significant software advancements for our first-in-class ultra-low-field Swoop Portable MR Imaging System to deliver diagnostic-quality brain images that enable timely clinical decision-making at the point of care,” said Maria Sainz, president and CEO of Hyperfine Inc. “We are committed to continuous improvement to optimize the clinical utility of the Swoop system while driving commercial adoption across leading institutions globally. We have released two new sequences (T1 Standard and Fast T2) in the last twelve months, improved DWI sequence image quality twice, and expanded the system’s field for view.”
 
Hyperfine Inc. first received initial FDA clearance for the Swoop Portable MR Imaging System in 2020 and has received two additional FDA clearances for hardware improvements and seven clearances for upgraded software, including BrainInsight software—with five of these clearances received in 2022. Hyperfine Inc. maintains a total installed base of 100 Swoop systems globally, and twenty peer-reviewed clinical publications have included Swoop system data.
 
“We’re investing heavily in software development, AI, and image quality and are committed to expanding the toolbox available to our users,” said Tom Teisseyre, chief product officer of Hyperfine Inc. “These initiatives are core to our transformative approach to MR imaging, making it a reality for a growing number of patients in the fast-evolving diversity of sites of care.”