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Universal-brain

San Francisco, CA

  • EEG and neural monitoring

UniversalBrain develops objective brain measurement tools designed to bring data-driven decision-making to psychiatry. Its FDA 510(k)-cleared UB ERP System uses dry-EEG and event-related potentials to record brain activity and provide clinicians with an aid to diagnosis.

FDA 510(k)
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reccy insights

Recent highlights

Universal Brain’s publicly documented product focus is its UB ERP System, an FDA 510(k)-cleared Class II medical device intended to support objective brain-function measurement in psychiatry. The system combines a dry-EEG cap with event-related potential measurement and produces ERP reports for clinical, trial, and research applications. Its stated use case addresses a persistent challenge in psychiatric care: making treatment and diagnostic decisions with more physiological evidence and less reliance on trial-and-error approaches. The system supports multiple task paradigms, including oddball, flankers, and doors tasks, and includes P300 ERP measurement, eye-movement correction, and photodiode-based visual stimulus timing. As a result, the company’s recent commercial momentum and adoption cannot be independently characterized beyond its regulatory-cleared product positioning.

Written by reccy's AI from company sites, press and funding records · updated Oct 2026

What makes Universal-brain distinct

  1. 01Brings objective brain-function measurements to psychiatry, reducing reliance on trial-and-error decision-making.
  2. 02FDA 510(k)-cleared Class II medical device designed for clinical use.
  3. 03Dry-EEG cap enables rapid setup without requiring a specialist laboratory.
  4. 04Measures event-related potentials through multiple clinical task paradigms and generates ERP reports.
  5. 05Supports clinical, trial, and research applications through a modular, Windows-compatible system.

Technology & products

  • UB ERP System

    An FDA 510(k)-cleared system using dry-EEG and event-related potentials to record brain activity and provide clinicians with an aid to diagnosis.

  • UB ERP System
  • Dry-EEG electrode cap
  • Event-related potential measurement
  • P300 ERP measurement
  • EEG recording with eye-movement correction
  • Photodiode-based visual stimulus timing

FDA regulatory

  • 510(k)· Class II
    UB ERP System

    Non-Normalizing Quantitative Electroencephalograph Software · K253767 · product code OLT

    Cleared Jun 30, 2026