Hyperfine Announces FDA Clearance for Improved AI-Powered Software

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Hyperfine announced the U.S. FDA 510(k) clearance and launch of the company’s upgraded AI-powered software. Latest Swoop® software improves image quality for DWI imaging of the brain. 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.

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 percent 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.

When interpreted by a trained physician, these images provide useful information in determining a diagnosis. The Swoop® system is approved for brain imaging in several countries, including Canada and Australia, has UKCA certification in the United Kingdom, and is also available in New Zealand and Pakistan.