Oxford Brain Diagnostics has been granted FDA Clearance for its novel MRI Software
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…
