The FDA has granted Breakthrough Device designation to XCSITE, a non-invasive brain stimulation platform developed by Pulvinar Neuro for treating major depressive disorder. Created and patented by Flavio Frohlich, PhD, professor of psychiatry at the UNC School of Medicine, the device represents a significant advancement in depression treatment. The Breakthrough Devices Program supports manufacturers in getting devices to market more quickly, providing patients timely access to cutting-edge technologies that can lead to more effective treatment and diagnosis of life-threatening or incapacitating conditions.
The XCSITE platform emits very weak electrical currents to the brain, altering brain waves implicated in depression. The device detects an individual’s distinct brain waves through an electroencephalogram (EEG) and once recorded, emits very weak electrical currents to alter the disrupted electric activity in the brain, causing little to no sensation to the wearer. According to the National Institute of Mental Health, in 2020 an estimated 14.8 million U.S. adults aged 18 or older had at least one major depressive episode with severe impairment in the past year. Depression is typically treated with psychotherapy and antidepressant medication, but medication is not always effective, and adherence can be difficult.
In August 2024, a clinical trial led by Frohlich and David Rubinow, MD, demonstrated the efficacy of the device, finding that use significantly reduced symptom severity among participants with major depressive disorder, with 80% of patients declared free of clinical depression symptoms two weeks post-treatment. The device is designed for acute reduction and treatment of depression symptoms in adult patients who do not respond to standard pharmacological treatment and is intended to be used acutely within two weeks of finishing treatment.
Pulvinar Neuro was founded in 2016 by Frohlich and was acquired in 2022 by Electromedical Products International, Inc. (EPI), a private medical device manufacturer and leader in non-invasive brain stimulation for psychiatric disorders, to accelerate the clinical trials program toward FDA approval.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://news.unchealthcare.org/2025/03/fda-grants-breakthrough-device-designation-for-non-invasive-brain-stimulation-device-to-treat-major-depressive-disorder/