FDA Clears Universal Brain’s Rapid Brain-Function Platform for Psychiatry

Neurotech company Universal Brain (UB) announced that it’s earned 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a system that measures brain function using electroencephalography (EEG) and event-related potentials (ERPs).

The UB ERP system merges a proprietary, dry-electrode EEG wearable styled like a baseball cap with the company’s Neurotique ERP software to quickly capture objective brain function measurements. Universal Brain hopes that the FDA nod will help bring objective, neuroscience-based brain function evaluation into routine psychiatric care and clinical research.

Psychiatry has few objective tools to measure the biology of mental illness, leaving clinicians to rely on symptom-based evaluations and trial-and-error treatment choices. Founded in 2022, the San Francisco-based company aims to leverage its UB ERP system to support selection of the optimal treatments, monitor therapeutic response, and collect objective biomarkers that improve precision of CNS (central nervous system) drug development.

The company recently began two studies to validate its platform in patients suffering from depression:

• A multicenter study with Adams Clinical sites in Boston and New York evaluating brain function and clinical outcomes before and after first-line antidepressant treatment to develop biomarkers predictive of treatment response
• A multicenter longitudinal study across leading Japanese hospitals evaluating patients over 24 weeks following treatment initiation to develop objective brain function markers associated with antidepressant response

A recent $2 million Japan Agency for Medical Research and Development grant will also support multi-site clinical studies and sales efforts. The company plans to launch the UB ERP system in the U.S. later this year.

Comments from Universal Brain and clinicians

Kazu Okuda, MD, founder and CEO: “This FDA clearance represents a major milestone towards bringing objective brain function measurement into everyday psychiatric care. By measuring neural responses across cognitive and emotional tasks, we can begin to understand how each patient’s brain is functioning rather than relying solely on symptoms. Our vision is to enable more personalized treatment decisions and accelerate the development of better therapies for patients with mental health disorders.”

K. Luan Phan, Chair of Psychiatry at The Ohio State University College of Medicine; newly-appointed chief medical advisor, Universal Brain: “Objective brain-function measurement has the potential to fundamentally change how we diagnose and treat psychiatric disorders. Universal Brain’s rapid ERP platform brings rigorous neuroscience into everyday clinical practice in a way that has never been possible. With this technology, we can move beyond symptom checklists and begin to understand the underlying brain systems driving each patient’s illness, and how those systems change with treatment.”