SwiftMR
AIRS Medical Inc.SwiftMR is a software medical device designed to automatically enhance brain MRI images by reducing noise and improving image sharpness. It processes MRI scans in DICOM format using advanced deep learning models, helping radiology professionals obtain clearer images for better diagnosis and clinical decision-making without interrupting their workflow.
Intended Use
SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of brain MRI images in DICOM format. It can be used for noise reduction and increasing image sharpness for non-contrast enhanced MRI images.
Technology
SwiftMR is a standalone software medical device consisting of deep learning algorithms that process standard-of-care MRI images in DICOM format to produce enhanced images with noise reduction and increased sharpness simultaneously. It supports two algorithms for different pulse sequences and integrates with facility PACS for automatic image quality enhancement and workflow integration.
Performance
Performance testing included verification and validation activities with retrospective clinical images showing that the software increased signal-to-noise ratio by at least 40% and reduced FWHM (sharpness measure) by at least 0.13% in over 90% of test datasets, demonstrating substantial equivalence to a predicate device and meeting preset acceptance criteria.
Predicate Devices
No predicate devices specified
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