Cirrus Resting State fMRI Software
Sora Neuroscience, Inc.Cirrus Resting State fMRI Software is a medical imaging software that processes resting state functional MRI data to generate brain maps showing motor, language, and vision networks. These maps assist clinicians such as surgeons and radiologists in visualizing functional areas of the brain non-invasively, aiding in pre-surgical planning and clinical decision-making.
Intended Use
Cirrus Resting State fMRI Software performs magnetic resonance image processing including BOLD functional MRI data processing, resting state fMRI analysis, and output generation of motor, language, and vision resting state fMRI correlation maps in DICOM format for visualization and analysis external to Cirrus.
Technology
Cirrus is a software as a medical device (SaMD) that processes individual patient brain MRI datasets containing BOLD fMRI and structural MRI data using preprocessing tools, voxel-wise correlation map generators, and a resting state network membership scoring algorithm based on machine learning. It outputs patient-specific correlation maps of sensorimotor, language, and vision networks in DICOM format.
Performance
Performance testing included software unit and verification testing, clinical performance validation on data from adults and children with brain tumors and epilepsy, and cybersecurity testing. Validation studies demonstrated the software-generated resting state network maps are consistent with task-based fMRI and intraoperative stimulation mapping, with high spatial correlation values and ROC analysis AUC of 0.84 for vision maps. Testing also showed robust reproducibility across MRI scanner types (Siemens and GE).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/1/2025
2 months - 2
FDA Approval
6/6/2025
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