What's Happening?
Flow Neuroscience has received FDA approval for its FL-100 wearable device, designed to treat major depressive disorder (MDD) at home. The device uses transcranial direct current stimulation (tCDS) to apply
a weak current to the brain's prefrontal cortex, enhancing neuron excitability. This non-invasive treatment offers an alternative to traditional antidepressants, which can have long-term side effects. The FL-100 has been trialed in the UK and other markets, showing significant improvement in depressive symptoms. It is set to launch in the U.S. in 2026.
Why It's Important?
The approval of the FL-100 device represents a significant shift in depression treatment, moving from pharmaceutical to tech-based therapies. This development is crucial as depression rates in the U.S. have surged, affecting over 20 million adults. The device's ability to be used at home could increase accessibility to effective treatment, potentially reducing the burden on healthcare systems and improving patient outcomes.
What's Next?
Flow Neuroscience plans to launch the FL-100 in the U.S. by the second quarter of 2026. The company aims to make non-drug treatments more accessible to Americans suffering from depression. The success of this device could pave the way for further innovations in mental health treatment, encouraging more tech-based solutions.
