Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Cercare Medical A/SCercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.
Intended Use
An image processing software package used by trained professionals to perform image viewing, processing, and analysis of imaging data acquired through DICOM compliant imaging devices, specifically providing visualization and analysis of MRI and CT neuroimaging data for stroke patient assessment.
Technology
Software-only platform that processes DICOM images from MRI and CT modalities, providing visualization, quantification, and analysis of perfusion and diffusion imaging data. It includes dynamic analysis modules for calculation of tissue perfusion parameters and a Virtual Expert module for automatic region-of-interest delineation related to stroke evaluation. Operates on standard computers or virtual platforms and integrates into radiology data networks securely.
Performance
The device underwent extensive software verification, validation, and performance testing involving simulated digital phantoms and retrospective clinical data. Results demonstrated accurate representation of key parameters, comparable to the predicate device and a well-established reference device, with no new safety or effectiveness issues identified.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/8/2024
5 months - 2
FDA Approval
12/6/2024
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