Flow Neuroscience
On December 11, 2025, the Federal Drug Administration (FDA) made groundbreaking approval of its first-ever nondrug, at-home treatment for depression.
The FL-100, manufactured by Swedish company Flow Neuroscience, works by providing electrical stimulation to the prefrontal cortex of the user. The prefrontal cortex, responsible for executive functions including judgment and planning, is also implicated in emotional regulation. Importantly, it is often underactive in patients with depression. Since the device was released in 2019, Flow states they have helped 55,000 patients throughout the EU.
However, the FDA’s decision to approve the FL-100 at this point was likely due to a clinical trial published in Nature Medicine in October of last year. The trial procedure consisted of half-hour sessions conducted 3-5 times per week over the course of 10 weeks. 58% of patients were in remission by the end of the trial, indicating the effectiveness of the treatment. Additionally, Flow’s Chief Medical Officer Dr. Kultar Garcha claims that 77% of patients in the real-world see benefits in only 3 weeks. Compared to other depression treatments, Flow’s advantages include at-home convenience and efficiency.
They are aiming for a retail price of $500 to $800 upon launch in the US in mid-2026.
Inside the Mind 