FDA Clears Brain MRI-Based Software for Assessing Cortical Disarray Measurement

The Food and Drug Administration (FDA) has granted 510(k) clearance for CDM Insights, a magnetic resonance imaging (MRI)-based software that may facilitate early detection of neurodegeneration.

The cloud-native CDM (Cortical Disarray Measurement) Insights software enables neuroradiologists to assess new measurements of brain microstructure and cortical thickness that were previously unavailable in the United States, according to Oxford Brian Diagnostics, the developer of the CDM Insights software.

"Our technology empowers clinicians with the tools they need to detect subtle brain changes and to diagnose with confidence at an early stage,” noted Steven Chance, Ph.D., the CEO and co-founder of Oxford Brian Diagnostics. “These insights also help patients gain a better understanding of the changes happening in their brains, addressing the uncertainty often experienced with the early signs of Alzheimer's disease. Ultimately, this enables providers … to understand patient brain structure changes prior to symptom progression and improve patient outcomes."

The company said CDM Insights allows clinicians to monitor brain changes across multiple stages of adult life and enables assessment of patients with neurodegenerative disorders such as Alzheimer’s disease. The software can be utilized with scans from 1.5T or 3T MRI devices, according to Oxford Brain Diagnostics.