Combinostics gets FDA clearance for quantification software

Finnish software developer Combinostics has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cNeuro cMRI quantification software.

Designed to provide automated objective measurements of atrophy in different brain regions and also information about the amount of white-matter hyperintensities, the cloud-based software quantifies 133 brain regions and then compares the calculated volumes to a normative database, according to the firm. It then provides clinicians with an overview of any abnormal atrophy or white-matter changes, which is useful for assessing dementia and other neurodegenerative diseases, Combinostics said.

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