Overview
On July 13, 2026, Universal Brain received FDA 510(k) clearance for its UB ERP System — a dry-electrode EEG wearable paired with proprietary software that delivers objective brain function measurements in under five minutes. This marks a significant milestone in the long push to bring biological objectivity to psychiatric diagnosis.
How It Works
The system uses a portable, dry-electrode EEG headset that patients can wear during a brief office visit. The device measures event-related potentials (ERPs) — electrical brain responses to specific stimuli — and processes them through machine learning algorithms trained on large clinical datasets. The result is a quantitative brain function report that clinicians can use alongside traditional assessments.
Why This Matters
Psychiatry has historically relied almost entirely on patient-reported symptoms and clinician observation. Unlike cardiology (EKG), neurology (EEG), or oncology (biopsy), mental health has lacked routine biological measurements. Universal Brain's clearance represents a paradigm shift: the possibility of diagnosing depression, ADHD, anxiety, and other conditions with the same objectivity used in other medical specialties.
Clinical Applications
The system is designed for use in primary care and psychiatric offices, where it can screen for conditions, track treatment response over time, and help clinicians make more informed medication decisions based on individual brain physiology rather than trial-and-error.
