Oxford Brain Diagnostics awarded Breakthrough Device Designation by the US Federal Drug Administration (FDA)
Spun out of the University of Oxford in 2018, OIC portfolio company Oxford Brain Diagnostics (OBD) specialises in the measurement of neurodegeneration in Alzheimer’s disease.
OBD has announced that it has achieved Breakthrough Device Designation by the Federal Drug Administration (FDA) for its Cortical Disarray Measurement (CDM®) Software Device for evaluating adults at risk of Alzheimer’s disease.
OBD’s first product from its software platform will be a breakthrough in the evaluation of adult patients with Mild Cognitive Impairment (MCI) who are being evaluated for Alzheimer’s disease.
The CDM Software Device, used as an adjunct to other diagnostic evaluations, is intended to predict conversion from MCI to Alzheimer’s disease in patients previously diagnosed with MCI. CDM technology uses non-invasive MRI brain scan data linked to changes in the brain at a cellular level, offering sensitive and accurate assessment of the neurodegeneration associated with Alzheimer’s disease and other dementias.
Click here for the official company press release.