Flow Neuroscience, a small Swedish company treating depression with brain-stimulating headsets, released early data on Monday showing that its device relieved depressive symptoms in clinical trials.
The company has not yet formally written up the data for a journal. But Flow leaders have included the data in an application for Food and Drug Administration approval and provided STAT with topline data ahead of releasing them publicly. If the trial methods and results hold up under the FDA’s scrutiny, it would be the first device of its kind approved to treat depression in the United States. Flow already sells its devices over-the-counter in Europe, where it received regulatory approval in 2019.
“I’m very intrigued and hopeful, but at the same time I’m a little bit skeptical and want to see all these details,” said Mark George, a psychiatry professor at the Medical University of South Carolina who was not involved with the trial.