San Francisco — Universal Brain has received U.S. Food and Drug Administration 510(k) clearance for its UB ERP System, a platform designed to rapidly measure brain function using electroencephalography and event-related potentials.
The neurotechnology company said the system could support more objective assessment in psychiatric care and clinical research, where diagnosis and treatment decisions have traditionally relied heavily on reported symptoms.
The platform combines a proprietary dry-electrode EEG wearable with Universal Brain’s Neurotique ERP software. According to the company, clinicians can set up the device, perform an assessment and receive analyzed results in less than five minutes.
“This FDA clearance represents a major milestone towards bringing objective brain function measurement into everyday psychiatric care,” said Kazu Okuda, founder and chief executive officer of Universal Brain. “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.”
Universal Brain is developing the technology to support treatment selection, monitor therapeutic response and identify biomarkers that could improve central nervous system drug development.
The company has launched two studies involving patients with depression. A multicenter U.S. study at Adams Clinical sites in Boston and New York will evaluate brain function and clinical outcomes before and after first-line antidepressant treatment. A separate 24-week study at hospitals in Japan will examine brain-function markers associated with treatment response.
Universal Brain also appointed K. Luan Phan, chair of psychiatry at The Ohio State University College of Medicine, as chief medical adviser.
“Objective brain-function measurement has the potential to fundamentally change how we diagnose and treat psychiatric disorders,” Phan said. “Universal Brain’s rapid ERP platform brings rigorous neuroscience into everyday clinical practice in a way that has never been possible.”
The company has also received a $2 million grant from the Japan Agency for Medical Research and Development to support multisite clinical studies and commercialization.
Universal Brain is preparing to commercially launch the system later this year and plans to continue studying its use in predicting treatment response across psychiatric and neurological conditions.
