News

The Washington Post (12/11, Gilbert) reports the FDA has approved “an in-home headset that allows people with depression to send mild electrical current to their brains.” The prescription device, made by Flow Neuroscience, “is designed to counteract moderate to severe depression in adults by delivering electric stimulation to an area of the brain that controls mood and stress.” Although electric stimulation is “widely used to treat depression,” the company is “aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics.” Reuters (12/11, Choudhury) adds that the “device is cleared to treat moderate to severe major depressive disorders in adults aged 18 and older, as a standalone treatment or alongside other treatments, who are not considered resistant to medication. Flow plans to launch the device in the U.S. in the second quarter of 2026 as a prescription-only treatment.” The company “is negotiating with insurance payers and expects to announce coverage partnerships in early 2026.” (SOURCE: APA Headlines)