Oxford Brain Diagnostics (OBD) is set to launch its CDM Insights software in the U.S. following its FDA 510(k) clearance in January 2025. The tool, designed to support early detection of dementia, uses MRI data to assess brain changes and delivers objective, quantifiable metrics on neurodegeneration.
The cloud-based platform analyses cortical thickness and micro- and macrostructural features, offering clinicians insights not currently available in the U.S. market. The software, which received breakthrough device designation in 2020, will be accessible to neurologists and radiologists across healthcare facilities.
Spun out of the University of Oxford in 2018, OBD attributes its commercial readiness to a 2023 funding round led by Business Growth Fund (BGF) and supported by Oxford Technology & Innovations Fund (OTIF).
The move reflects a growing focus on early neurodegeneration detection, with pharmacological studies—like Roche’s OLE trial of gantenerumab—highlighting its potential in delaying symptom onset.
03-06-2025