Swoop Portable MR Imaging System
Hyperfine, Inc.The Swoop Portable MR Imaging System by Hyperfine is a bedside MRI device that allows clinicians to capture magnetic resonance images of the head without moving the patient. It utilizes advanced deep learning-based image reconstruction to improve image quality, reducing noise and blurring. This portable device helps provide timely diagnostic information in critical care settings where traditional MRI is difficult.
Intended Use
The Swoop Portable MR Imaging System is a bedside 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 a portable MRI with a 63.3 mT permanent magnet and advanced grid image reconstruction enhanced by deep learning. The user interface is a commercial off-the-shelf tablet with touch screen menus for system operation and image viewing. The device generates MRI data sets with T1W, T2W, FLAIR, and DWI contrasts, with advanced post-processing including denoising, distortion correction, and coil intensity correction.
Performance
Verification and validation testing demonstrated that the device meets user needs and image quality criteria, passing standards for software, safety, biocompatibility, cleaning, and cybersecurity. Testing leveraged predicate device data to confirm no new safety or effectiveness issues.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/21/2022
1 month - 2
FDA Approval
12/6/2022
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