Oxford Brain Diagnostics’ CDM Insights software has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA).
Powered by the Oxford, England-based company’s cortical disarray measurement technology, CDM Insights allows for clinical assessment of the brain’s microstructures via MRI scans. Healthcare practitioners can use this data to evaluate patients with neurodegenerative disorders such as Alzheimer’s disease.
The software includes new measurements of microstructure and cortical thickness. It will also provide macrostructural measures.
CDM Insights is cloud-native, noninvasive, and monitors brain changes in patients across the many stages of adult life. It processes clinical MRI scan data from both 1.5-tesla and 3-tesla scanners and delivers outputs in the form of images and numerical values.
The company said the software will be available to all U.S. healthcare facilities and is intended for use by neurologists, radiologists, and other trained healthcare practitioners familiar with the post-processing of MR images. It added that CDM Insights is not intended to be used in isolation for diagnosis or treatment decisions, but that the physician should retain responsibility for making any final diagnosis and treatment decisions.