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# Improved Swoop Portable Brain MRI Cleared
- URL: https://www.fdaweb.com/improved-swoop-portable-brain-mri-cleared/
- Published: 2025-06-02T12:00:00.000Z
- Updated: 2026-09-14T15:13:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159283

FDA has cleared a Hyperfine 510(k) for its next-generation AI-powered portable MRI system for the brain, the Swoop system. The clearance includes a new portable MRI scanner powered by the proprietary Optive AI software that helps to deliver high image quality and functionality, according to the company.

The device “incorporates learnings from five years of real-world experience across seven continents and numerous care settings,” Hyperfine says. “The new Swoop system features innovations specifically engineered to deliver the highest signal-to-noise ratio, which, when paired with the Optive AI software, achieve exceptional image quality, including improved resolution, uniformity, and faster acquisition times.”