FDA clears CereMetrix® Silver neuroimaging analytics and clinical workflow platform

CereMetrix® Silver, a neuroimaging analytics and quantification platform, has received 510(k) clearance from the the U.S. Food and Drug Administration (FDA), CereMetrix, a subsidiary of CereHealth reported today. The Littleton, CO-headquarted company said that the platform provides objective neuroimaging that detects, quantifies, and analyzes brain function down to the voxel level.

The CereMetrix Silver image viewer is designed to be used with brain images generated from computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), and single-photon emission tomography (SPECT) scans. The platform offers automated cluster analysis for quantitative and statisticaly analysis of SPECT brain scans by comparing them to other registered SPECT brain scans.

The company said that interpreting physicians can allow for the localization and definition of brain function, and that CereMetrix Silver can differentiate between hyper- and hypo-function in the brain. Radiologists and researchers can process and display the brain image data in traditional two-dimensional formats while simultaneously displaying pseudo three-dimensional renderings.

The neuroimaging platform is also designed to aid in the assessment of quantitative SPECT brain scans. Reconstructed brain imaging data will be mapped to a common brain template and anatomical map  before applying a clustering algorithm to group pixesl/voxes of tissue with deviations from average into clusters.