UK-based Oxford Brain Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval for its novel MRI Software, CDM Insights.
Designed using the company’s Cortical Disarray Measurement (CDM) technology, CDM Insights provides a deeper understanding of the brain’s microstructure from MRI scans.
The cloud-native software solution is non-invasive and monitors brain changes in patients across multiple stages of adult life.
It processes clinical MRI scan data from both 1.5T and 3T scanners and delivers outputs in the form of images and numerical values, presented as percentiles of population distribution.
With the FDA approval, the MRI software enables clinical brain assessment by trained healthcare practitioners evaluating patients with neurodegenerative disorders.
Oxford Brain Diagnostics CEO and co-founder Steven Chance said: “We are setting the new standard for precise measurement of cortical microstructure. This is a significant step on our global mission of ‘Rethinking Brain Health’.
“Our technology empowers clinicians with the tools they need to detect subtle brain changes and to diagnose with confidence at an early stage.
“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 and carers to understand patient brain structure changes prior to symptom progression and improve patient outcomes.”
According to Oxford Brain Diagnostics, CDM Insights includes new measurements of microstructure and cortical thickness, which was previously unavailable in the US market.
It will support clinicians with the early detection of neurodegeneration in patients and provide macrostructural measures, as part of the standard delivery.
CDM Insights is not intended for use in isolation for diagnosis or treatment decisions, and physicians are responsible for any final diagnosis and treatment decisions.
The product will be available to all US healthcare facilities, for use by neurologists, radiologists, and other trained healthcare practitioners.
