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)FDA clearance (510(k))
- 1
reccy insights
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
- 01Brings objective brain-function measurements to psychiatry, reducing reliance on trial-and-error decision-making.
- 02FDA 510(k)-cleared Class II medical device designed for clinical use.
- 03Dry-EEG cap enables rapid setup without requiring a specialist laboratory.
- 04Measures event-related potentials through multiple clinical task paradigms and generates ERP reports.
- 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 IIClass IIUB ERP System
Non-Normalizing Quantitative Electroencephalograph Software · K253767 · product code OLT
Cleared Jun 30, 2026
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About Universal-brain
- Products
- UB ERP System
- Focus areas
- Medical devices, digital health, diagnostics, neurotechnology, EEG, psychiatry, clinical research, brain data
- Headquarters
- San Francisco, CA