FDA Clears At-Home Brain Stimulation Device for Depression

The FDA cleared Flow Neuroscience's FL-100, an at-home transcranial direct current stimulation headset for depression, following a remote clinical trial showing 45% remission rates versus 22% in controls. The device becomes available in the US on 1 September 2026 and can be used standalone or alongside antidepressants and psychotherapy.

This Wire brief sits within Fusion42's coverage of Digital Health. Wire is Fusion42's founder-focused intelligence feed: each story is connected to the funds and startups it names — every one with a live profile on Raise or Scout — so founders can follow the capital and the momentum behind the headline rather than just the headline itself. Wire analysis is one of the live surfaces Arthur reasons over.