By Daniel Gilbert
The Washington Post
An in-home headset that allows people with depression to send mild electrical current to their brains has been cleared by the Food and Drug Administration, in what medical experts consider a milestone for expanding mental health treatment beyond drugs.
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. While such stimulation is widely used to treat depression, Flow is aiming to fill a niche with a product that delivers a relatively low dose of current at home, instead of at specialized clinics. The FDA said testing showed “modest” results for patients.
“We’re really about the democratization of access,” Erin Lee, Flow’s CEO, said in an interview, pointing out that many people lack access to in-office procedures such as transcranial magnetic stimulation. “We can put it in any home in the United States,” Lee said of Flow’s headset.
The device is cleared for use as a stand-alone therapy or in combination with drugs such as antidepressants. Pricing is still being finalized, but the headset will cost around $500, Lee said, and will be available in the United States by the middle of next year. She added that the company is in discussions with insurance companies and hopes to get coverage by the end of 2026.
Flow’s device uses transcranial direct ...

1 month ago
1














English (US) ·