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# Hyperfine MRI Image Reconstruction Cleared
- URL: https://www.fdaweb.com/hyperfine-mri-image-reconstruction-cleared/
- Published: 2021-11-29T12:00:00.000Z
- Updated: 2026-09-14T17:23:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150656

FDA has cleared a Hyperfine 510(k) for its advanced image reconstruction technology that uses deep learning to improve magnetic resonance imaging (MRI) on its Swoop MRI device. “The image quality resulting from this innovative approach elevates the diagnostic value of portable MRI,” the company says. The artificial intelligence application used with Swoop measures brain structure and pathology in images using tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift to diagnose and measure acute neurological conditions, it says.