Indications for Use
Neosoma Brain Mets
The Neosoma software uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) known or previously diagnosed brain tumors on MRI images for qualified and trained medical professionals. The technology is meant for informational purposes only and not intended to replace the clinician’s current standard practice of manual contouring. The software does not alter the original MRI image, nor is it intended to be used to detect tumors for diagnosis. The software is intended to be used on adult patients only. When using the Neosoma software in a radiation oncology planning workflow, or other clinical workflows, it is intended for generating Gross Tumor Volume (GTV) contours. For all clinical workflows, medical professionals must finalize (confirm or modify) the contours generated by the Neosoma software, as necessary, using an external platform available at the facility that supports DICOM viewing/editing functions, such as image visualization software and treatment planning system.
Neosoma Glioma
Neosoma Glioma is intended for the semi-automatic labeling, visualization, and volumetric quantification of high-grade brain glioma (WHO grade 3 astrocytoma, WHO grade 4 astrocytoma and WHO grade 4 glioblastoma) from a set of standard MRI images of male or female patients 18 years of age or older who are known to have pathologically proven high-grade glioma. Volumetric measurements may be compared to past measurements if available. Neosoma Glioma is not to be used for primary diagnosis, and is intended to be used by qualified clinical personnel as an additional source of information and is not intended to be the sole diagnostic metric.