News & Press
Universal Brain Receives FDA 510(k) Clearance for Rapid Brain-Function Measurement Platform for Psychiatry
www.businesswire.com7/13/2026·07/13/26🌐 USA
Summary
Universal Brain announced FDA 510(k) clearance for its UB ERP System, a dry-electrode EEG wearable with Neurotique ERP software that measures brain function via event-related potentials in under five minutes. The clearance advances objective, neuroscience-based assessment for psychiatric care and CNS drug development, enabling treatment selection, response monitoring, and biomarker discovery beyond symptom checklists.
Why it matters
FDA clearance for a rapid brain-function measurement platform gives psychiatry a faster objective assessment tool, addressing the field's long-standing reliance on subjective patient-reported symptom scales.
#EEG#FDA Approved#Depression#Clinical Trial
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