Combinostics receives FDA clearance for cNeuro cMRI

Tampere, Finland, January 15, 2018 – The digital health company Combinostics received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its image quantification software cNeuro cMRI. The software enables clinicians to get objective measurements of atrophy in different brain regions as well as information about amount of white matter hyperintensities, which are particularly useful in dementia and other neurodegenerative diseases. The software quantifies 133 brain regions and calculated volumes are compared to a normative database. The statistical comparison allows clinicians to quickly get an overview of whether there is abnormal atrophy or white matter changes, and in what brain regions.

Artificial intelligence, AI, is a hot topic promising major changes in medicine. Fully automatic image quantification, as provided by cNeuro cMRI, is part of this change. Today, interpretation of radiology images is very much based on visual assessment alone. However, identifying subtle changes is difficult and tools like cNeuro cMRI help radiologists create high quality reports in shorter time.

Our goal is to provide AI and machine learning solutions that help physicians in their daily decision making in neurology. Receiving FDA 510(k) clearance for cNeuro cMRI is an important milestone for us on this journey.

Combinostics is a Finnish digital health company that develops and markets advanced tools for data-driven diagnostics. The technology is generic and can be applied to any disease area but Combinostics’ first application concerns early detection and differential diagnostics in Alzheimer’s disease and other dementias. Combinostics’ cNeuro® platform includes cMRI for quantification of MRI brain scans and cDSI for data-driven clinical decision support in dementia. cNeuro cMRI and cDSI have been certified according to the European Medical Device Directive (93/42/EEC) and are available for clinical use in Europe. In the US, cNeuro cMRI is now cleared for clinical use but cDSI is not yet cleared for commercial sale in the US.

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