FDA approved Flow Neuroscience's FL-100 on December 8 under P230024. The headset delivers transcranial direct current stimulation to the prefrontal cortex. The label covers moderate to severe major depressive disorder in adults 18 and older who are not treatment refractory, as monotherapy or alongside medication. It is the first prescription at-home tDCS device approved in the US.
FDA received the PMA on August 7, 2023, so the review took 854 days. The supporting trial randomized 174 patients to active or sham stimulation for 10 weeks at home, with results published in Nature Medicine in 2024. Flow reports 58% of treated patients reached remission by week 10. Sessions run 30 minutes, five times a week for three weeks and then three times a week. Product code JXK, cranial electrotherapy stimulator for depression.
The Malmö company was founded in 2016 by Daniel Månsson and Erik Rehn. It launched in the UK in 2019. More than 55,000 people have used the device across the EU, the NHS, Switzerland and Hong Kong, the company says. Khosla Ventures led a 7.9 million euro Series A in 2021. CEO Erin Lee plans US availability in the second quarter of 2026. For a Class III depression device, a 174-patient sham-controlled trial plus six years of European use is a lean evidence package.