Universal Brain Receives FDA 510(k) Clearance for Rapid Brain-Function Measurement Platform for Psychiatry
Novel technology paves the way for objective brain function measurement to support precision psychiatry and accelerate CNS drug development
SAN FRANCISCO–(BUSINESS WIRE)–Universal Brain, a neurotechnology company pioneering objective brain-function measurement for mental health, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its proprietary UB ERP System, which measures brain function using electroencephalography (EEG) and event-related potentials (ERPs). The clearance marks an important step toward bringing objective, neuroscience-based brain function assessment into routine psychiatric care and clinical research.
Psychiatry has historically relied on symptom-based evaluations and trial-and-error treatment selection, with few objective tools available to measure the underlying biology of mental illness. Universal Brain’s platform combines a proprietary dry-electrode EEG wearable with its Neurotique™ ERP software to rapidly capture objective measures of brain function, reducing the time and complexity associated with conventional EEG systems. From device setup to analyzed results, clinicians can complete a single neural assessment in under five minutes.
