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.
