Swoop® Portable MR Imaging® System
Hyperfine, Inc.The Swoop Portable MR Imaging System is a portable, ultra-low field MRI scanner designed for imaging the head. It incorporates deep learning techniques to improve image quality, making it easier for clinicians to obtain diagnostic imaging for patients when conventional MRI is not feasible. Its portability and AI-powered reconstruction help deliver timely, high-quality scans at the point of care, supporting quicker diagnosis and decision-making.
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
Portable, ultra-low field MRI system featuring deep learning-based image reconstruction to improve image quality of T1W, T2W, FLAIR, and DWI sequences. The system uses a touchscreen interface and standard MRI pulse sequences, with software modifications specific to reconstruction and user interface.
Performance
Performance was validated through software verification, image quality testing, cybersecurity, and clinical validation. Deep learning Advanced Reconstruction was tested for quality and diagnostic consistency compared to linear reconstruction, including assessment by board-certified radiologists. Advanced Reconstruction improved image quality metrics (NMSE, SSIM, CNR) without altering pathology, and received top ratings from expert reviewers. Testing also covered safety, biocompatibility, and validation against relevant standards.
Predicate Devices
No predicate devices specified
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