Intended Use

SwiftMR is a stand-alone software solution intended to be used for acceptance, enhancement and transfer of all body parts MR images in DICOM format. It can be used for noise reduction and increasing image sharpness for MR images.

Technology

SwiftMR is a software algorithm that enhances MRI images using a deep learning model performing noise reduction and sharpening. It adjusts denoising (levels 0 to 8) and sharpness (levels 0 to 5). The software runs automatically in the background, processes DICOM images from PACS or MRI, and transfers enhanced images back in DICOM format. It works across different field strengths (0.25T to 3.0T) and supports all body parts and most MRI sequences.

Performance

Validation testing demonstrated SwiftMR increased the signal-to-noise ratio (SNR) by 40% or more for at least 90% of datasets at level 1 noise reduction, with incremental increases at higher levels. Sharpness increase was validated by decreases in full width at half maximum (FWHM) of selected ROI by defined percentages, passing acceptance criteria in over 90% of datasets. Testing used retrospective clinical images from multiple manufacturers, field strengths, anatomical regions, and protocols.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    3/28/2023

    7 months
  • 2

    FDA Approval

    10/27/2023

Other devices from AIRS Medical Inc.

Ready to Sharpen Your Edge?

Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.

We respect your privacy. Unsubscribe at any time.