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# Hyperfine AI Swoop MR Software Cleared
- URL: https://www.fdaweb.com/hyperfine-ai-swoop-mr-software-cleared/
- Published: 2024-07-17T12:00:00.000Z
- Updated: 2026-09-14T14:35:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157373

FDA has cleared a Hyperfine 510(k) for the ninth generation of artificial intelligence-powered Swoop system software. The software is designed to significantly reduce scan times across multiple magnetic resonance (MR) sequences without sacrificing image quality, the company says. “These scan time reductions may enable Swoop system images to help speed up the diagnostic process in acute care settings, which is crucial for time-sensitive medical conditions such as stroke, where every second counts,” it says. “Reducing the overall acquisition time for sequences can also decrease the negative impact of patient motion on image quality.” The Swoop Portable MR Imaging system is an ultra-low-field magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical, Hyperfine says.