Oxford Brain Diagnostics is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for CDM Insights. Powered by our pioneering Cortical Disarray Measurement (CDM®) technology, CDM Insights provides a new and deeper understanding of the brain’s microstructure from MRI scans. The FDA cleared CDM Insights software enables clinical brain assessment by trained healthcare practitioners evaluating patients with neurodegenerative disorders such as Alzheimer’s disease.
CDM Insights includes new measurements of microstructure and cortical thickness previously not available on the US market, supporting clinicians to open the gateway into early detection of neurodegeneration in patients. As part of our standard delivery, the product will also provide macrostructural measures.
This all-in-one solution is cloud native, non-invasive and monitors brain changes in patients across the multiple stages of adult life. CDM Insights processes clinical MRI scan data from both 1.5T and 3T scanners and delivers outputs in the form of images and numerical values, usually presented as percentiles of a normative population distribution. CDM Insights will be available to all US healthcare facilities, intended for use by neurologists, radiologists, and other trained healthcare practitioners familiar with the post-processing of magnetic resonance images.
CDM Insights is not intended to be used in isolation for diagnosis or treatment decisions. The physician retains the ultimate responsibility for making any final diagnosis and treatment decisions.
