Swoop® Portable MR Imaging® System
Hyperfine, Inc.The Swoop® Portable MR Imaging® System is a portable, ultra-low field MRI device that produces images of the internal structure of the head. It incorporates a deep learning-based image reconstruction algorithm to enhance image quality, helping healthcare providers diagnose patients at the point of care, especially where full diagnostic exams are not practical.
Intended Use
The Swoop Portable MR Imaging System is a portable, 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. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Technology
The system is portable and uses an ultra-low field permanent magnet (63.3 mT) MRI. It includes advanced image reconstruction algorithms utilizing deep learning to improve image quality for multiple MRI sequences including T1W, T2W, FLAIR, and DWI. The user interface is provided via a commercial off-the-shelf tablet device for operation and image viewing.
Performance
Extensive non-clinical and clinical performance testing was conducted. Non-clinical testing included software verification, image quality tests against NEMA standards, cybersecurity assessments, and biocompatibility and safety tests. Clinical validation involved comparison of advanced reconstruction with linear reconstruction using multiple datasets, demonstrating improved image quality without loss of diagnostic fidelity, as evaluated by radiologists. Performance metrics such as normalized mean squared error (NMSE) and structural similarity index measure (SSIM) showed advanced reconstruction's superiority. Contrast-to-noise ratio (CNR) was also significantly improved, and expert radiologist reviews confirmed improved image quality while maintaining diagnostic consistency.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/24/2025
27 days - 2
FDA Approval
5/21/2025
Other devices from Hyperfine, Inc.
- Swoop® Portable MR Imaging® System (V2)2025 • 510K
- Swoop� Portable MR Imaging� System2024 • 510K
- Swoop� Portable MR Imaging System�2023 • 510K
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