nordicMEDiVA
NordicNeurolab ASnordicMEDiVA is an advanced software platform designed to analyze and visualize functional and dynamic MRI data of the brain. It automates image processing pipelines and provides clinicians with derived imaging parameters through a web-browser interface, facilitating the evaluation of brain function and structure to aid clinical decision-making.
Intended Use
An advanced visualization and processing platform providing algorithms to analyze functional and dynamic MRI data of the brain, accessible via web browser and interoperable with DICOM imaging platforms.
Technology
Software as a Medical Device (SaMD); server-client architecture using a GPU-enabled Linux host with Docker containerization; web-browser client interface; functionality includes a database, DICOM communication, APIs, visualization engine, and medical image analysis modules for BOLD-fMRI, diffusion MRI including tractography, and DSC-perfusion analysis; rule-based algorithms used; no neural networks; interoperability with MR scanners, PACS, and surgical navigation systems.
Performance
Non-clinical performance testing was performed demonstrating compliance with ISO 14971, IEC 62304, IEC 62366-1, IEC 82304-1 standards, as well as FDA guidance. Verification and validation testing including usability studies showed the software to be safe, effective, and comparable in results to predicate devices for diffusion, tractography, BOLD fMRI, and DSC perfusion analyses.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
10/1/2024
21 days - 2
FDA Approval
10/22/2024
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