StoryCommercial
Flow Neuroscience launches FDA-approved FL-100 in the US market
Flow Neuroscience began US commercial availability of the FL-100 on 1 September 2026 as a prescription-only treatment for adults aged 18+ with moderate-to-severe major depressive disorder. The device was made available through prescription to non-treatment-refractory patients, either as standalone therapy or alongside existing medications. The company has already established prescription relationships with healthcare providers across the US market.
- US commercial launch of the first FDA-approved at-home tDCS device available by prescription
- Device indicated for moderate-to-severe MDD in adults 18+ not meeting treatment-refractory criteria
- Combines wireless stimulation headset with mobile application for therapy support
- More than 65,000 prior users across Europe, UK, and Australia demonstrate established safety profile