MICSI-RMT
Microstructure Imaging, Inc.MICSI-RMT is a software medical device designed to improve head MRI images by reducing noise, enhancing image quality to assist radiologists. It processes functional and diffusion MRI images without a user interface, outputting enhanced images for better visualization of brain structures and activation maps, aiding in clinical MRI interpretation.
Intended Use
MICSI-RMT is an image processing software that can be used for image enhancement in MRI images. It can be used to reduce image noise for head MRI.
Technology
MICSI-RMT is a Software as a Medical Device (SaMD) that processes DICOM MRI images to denoise functional and diffusion MR images of the head, using principal component analysis algorithms. It operates automatically within a DICOM router/processor system, outputs enhanced images to PACS, and supports fMRI parametric maps using pre-existing hospital software.
Performance
Performance testing included software verification and a HIPAA-compliant, retrospective IRB-approved rater study comparing MICSI-RMT processed images to standard of care. Qualitative assessments by expert neuroradiologists showed improved image quality and low artifact presence (mean Likert > 3). Quantitative metrics (SNR change ≥5%, improved fMRI activation z-scores, and reduced standard deviation in dMRI parametric maps) met acceptance criteria, demonstrating substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/23/2024
2 months - 2
FDA Approval
7/17/2024
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