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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 companyโ€™s upgraded AI-powered software.ย Latest Swoopยฎ 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 Swoopยฎ 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 Swoopยฎ Portable MR Imagingยฎ System field of view by 10 percent for T1, T2, and FLAIR sequences to match the previously improved DWI sequenceโ€™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 Swoopยฎ 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.

 

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