Universal Brain receives FDA clearance for eight-channel EEG cap that measures brain activity in five minutes

Universal Brain announced FDA 510(k) clearance for its Neurotique platform, which delivers a five-minute assessment of cognitive and emotional brain function to support psychiatric diagnosis and treatment. The device is an eight-channel dry EEG baseball cap that includes two electrooculography electrodes, a rechargeable battery, and an integrated digital testing platform that uses event-related potentials to generate task-based measurements.

Forbes reported that CEO Kazu Okuda founded the company in 2022.

Greg Hajack, a clinical psychologist and professor at Santa Clara University who previously led Google X’s Project Amber, joined as chief scientist in 2024. That project, a three-year effort to identify a single biomarker for depression, ended in 2020. The company has raised $7.9 million in seed funding and secured a $2 million grant from Japan’s government.

It will begin selling the device this summer to a group of 250 clinics that have expressed early interest while also pursuing pharma contracts. Two active pilot projects are underway in mental health and mild cognitive impairment. Universal Brain announced two new studies in the United States and Japan focused on biomarkers of treatment resistance and treatment response.

The company will sell devices and charge a usage-based revenue share under existing CPT reimbursement codes for EEG and ERP recording. Okuda stated that the approach is ten times cheaper, ten times faster, and more reliable than current methods. The FDA first approved transcranial magnetic stimulation for treatment-resistant depression in 2008, and the company is targeting clinics that offer TMS and esketamine.