Swoop® Portable MR Imaging® System (V2)
Hyperfine, Inc.The Swoop® Portable MR Imaging® System (V2) by Hyperfine, Inc. is a portable, ultra-low field MRI device designed to image the internal structure of the head. It is intended for use in clinical settings where full diagnostic MRI exams may not be practical, providing clinicians with images that aid in diagnosis. The system features advanced image reconstruction using deep learning to optimize image quality, enhancing visualization while being convenient and fast to deploy at the point of care.
Intended Use
The Swoop® Portable MR Imaging® System (V2) 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 device is a portable, ultra-low field MRI with a permanent magnet of approximately 65 mT. It includes an off-the-shelf user interface device for scan setup and execution, provides access to various MRI sequences (T1W, T2W, FLAIR, DWI/ADC), and uses a deep learning image reconstruction algorithm called Advanced Reconstruction to enhance image quality relative to linear reconstruction methods.
Performance
Performance testing included verification and validation according to international standards (e.g., IEC 62304 for software, IEC 60601 series for safety), biocompatibility of patient-contacting materials, and cleaning/disinfection validation. Advanced Reconstruction was evaluated with a large independent dataset for robustness and image quality, showing improved metrics (NMSE, SSIM, contrast-to-noise ratio) and positive radiologist image quality assessments relative to linear reconstruction, without loss of diagnostic consistency or unexpected artifacts.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/27/2025
4 months - 2
FDA Approval
5/30/2025
Other devices from Hyperfine, Inc.
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