Health
FDA Clears At-Home Device to Treat Depression
Health Points
- The Flow FL-100 is the first at-home brain-stimulation device cleared by the FDA for major depression treatment.
- Clinical trials show the device can lead to higher rates of depression remission with minimal side effects.
- This wireless headset may appeal to adults seeking non-medication options for managing depression at home.
Americans seeking new approaches to ease depression will soon have access to a prescription device that uses a gentle electrical current to target key brain regions. The Flow FL-100 is set to launch in the U.S. in spring 2026, offering an at-home treatment option for adults with moderate to severe major depressive disorders.
“It’s another arrow in the quiver — an option that appears helpful for a meaningful subset of patients,” says Samuel Wilkinson, MD, an associate professor of psychiatry at Yale Medicine.
The Flow FL-100 uses transcranial direct current stimulation (tDCS), a low, noninvasive current delivered through scalp electrodes. Unlike electroconvulsive therapy, the FL-100’s current is much milder and designed to be comfortable for users.
A clinical trial involving 174 participants showed remission rates three times higher for users of the FL-100 compared to those receiving a placebo treatment. In the study, 45 percent of individuals using the device reached remission, versus 22 percent of the control group.
Benefits extended to improved mood, energy, sleep, focus, and reductions in anxiety. “As a noninvasive device approved for use both alone or alongside medication, it typically shows clinical results rapidly — often within just three to four weeks,” says Daniel Mansson, chief science officer and cofounder of Flow Neuroscience.
Minimal side effects such as mild tingling, brief irritation, or headache were reported. Skin burns were rare and linked to improper use, such as reusing electrodes or letting pads dry out.
Depression is linked to underactivity in the prefrontal cortex. The device aims to restore healthy brain function by delivering targeted electrical signals to the forehead.
“The FL-100 works by delivering a gentle, comfortable electrical signal to the forehead to restore healthy brain activity and reduce symptoms,” says Kultar Garcha, MD, chief medical officer at Flow Neuroscience.
Dr. Garcha points out the wireless headset is user-friendly, used at home in 30-minute sessions alongside a simple app, making it convenient and non-disruptive.
The device is especially suited for those earlier in their treatment journey or those desiring to avoid medication-related side effects. The projected retail price in the U.S. is between $500 and $800, with insurance coverage details still in discussion.
If you’re considering new ways to manage depression, talk to your healthcare provider about whether this innovative at-home device might fit your needs.