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# Hyperfine’s AI Brain Imaging Software Cleared
- URL: https://www.fdaweb.com/hyperfines-ai-brain-imaging-software-cleared/
- Published: 2023-10-10T12:00:00.000Z
- Updated: 2026-09-14T19:01:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155528

FDA has cleared a Hyperfine 510(k) for updated software for its portable magnetic resonance brain imaging system, the Swoop system. The artificial intelligence (AI)-based software —"brings image quality enhancements to the Swoop system’s diffusion-weighted imaging (DWI) sequence,” Hyperfine says, adding that it expands the device’s “AI denoising capabilities by incorporating advanced image post-processing into the DWI sequence. Denoising enables a crisper image that potentially helps clinicians more accurately diagnose, treat, and monitor patients undergoing brain imaging.”