Universal Brain has received US Food and Drug Administration (FDA) 510(k) clearance for its UB ERP System, a brain function assessment platform designed for use in psychiatry. The system uses electroencephalography (EEG) and event-related potentials (ERPs) to provide objective measurements of brain function.

The clearance supports the introduction of neuroscience-based brain function assessment into routine psychiatric care and clinical research, where treatment decisions have traditionally relied on symptom-based evaluations.

The UB ERP System combines the company's dry-electrode EEG wearable with its Neurotique ERP software, allowing clinicians to complete a brain function assessment in less than five minutes, from device setup to analysed results. The platform is designed to simplify EEG testing while providing objective data on cognitive and emotional brain responses.

Universal Brain is developing the technology to support treatment selection, monitor patient response to therapy and identify biomarkers that could improve the development of treatments for central nervous system disorders.

To further validate the platform, the company has launched two multicentre clinical studies in patients with depression. In the United States, the study is being conducted at Adams Clinical sites in Boston and New York to evaluate brain function and clinical outcomes before and after first-line antidepressant treatment. In Japan, a separate 24-week longitudinal study is being carried out across several hospitals to identify objective brain function markers associated with antidepressant response.

The company also announced the appointment of K. Luan Phan, Chair of Psychiatry at The Ohio State University College of Medicine, as its Chief Medical Advisor.

In addition, Universal Brain has secured a US$2 million grant from the Japan Agency for Medical Research and Development under its Next-Generation Medical Device Development Project. The funding will support multicentre clinical studies and commercialisation activities.

Universal Brain plans to launch the platform commercially later this year while continuing to generate clinical data to expand its use in predicting treatment response across a range of psychiatric conditions. The company aims to make rapid brain function assessment a routine part of psychiatric and neurological care.

 

Source: businesswire.com

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