Americans looking to relieve depression without medication will have a new option soon: a device that uses a gentle electrical current to stimulate a brain region involved in mood regulation.
The Flow FL-100 is the first at-home brain-stimulation device to be cleared by the U.S. Food and Drug Administration (FDA) for the treatment of major depression. It will be available by prescription only.
The manufacturer, Flow Neuroscience, plans to launch the device in the United States in spring 2026. The FL-100 is already available in Europe, the UK, Switzerland, and Hong Kong.
Scientists are continually looking for new depression treatments. While medications and talk therapy are effective for many people, symptom relief can be elusive, says Samuel Wilkinson, MD, an associate professor of psychiatry at Yale Medicine in New Haven, Connecticut.
The efficacy of the FL-100 is promising if somewhat limited, says Dr. Wilkinson, who wasn’t involved in the development of the device. “It’s another arrow in the quiver — an option that appears helpful for a meaningful subset of patients,” he says.
New Device Stimulates the Brain With Mild Electric Current
The FDA has cleared the Flow FL-100 to treat moderate to severe major depressive disorders in adults age 18 and older, as a standalone treatment or alongside other treatments, for individuals whose depression is not considered treatment-resistant.
Treatment-resistant depression is when a person has major depression that doesn’t significantly improve after they’ve tried at least two different antidepressant medications at the approved dose.
The new device works via transcranial direct current stimulation (tDCS) using a low, noninvasive direct current of 0.5 to 2 milliamperes administered by two electrodes positioned on the scalp.
That’s much weaker than electroconvulsive therapy (ECT), which delivers about 800 milliamperes to the brain — a current strong enough to cause seizures.
Nearly Half of Study Participants Achieved Remission
The FDA cleared the device after evaluating a randomized placebo-controlled clinical trial published in the journal Nature Medicine late last year. The trial included 174 adults who had a diagnosis of at least moderate depression.
Participants were randomly assigned to one of two treatment arms: “active” tDCS or “inactive” tDCS, which utilized the same device but did not issue a current.
Study subjects had a 10-week course of treatment, with five 30-minute sessions a week for the first three weeks, followed by three 30-minute sessions a week for the following seven weeks.
Researchers measured depression using a standardized rating scale commonly used in clinical trials that evaluated symptoms such as mood, concentration, anxiety, sleep, and daily functioning. Lower scores indicated fewer or less severe depressive symptoms, and people were considered in remission when their scores reached a level indicating they no longer met the criteria for major depression.
After 10 weeks of use:
- The rates of treatment response and remission were three times higher in the group using the FL-100 than in the placebo arm.
- A total of 45 percent of people in the active arm demonstrated a remission rate, compared with 22 percent of the control group.
Improvements were seen in mood, energy, sleep, concentration, and 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, the chief science officer and a cofounder of Flow Neuroscience.
“Crucially, because it targets the brain externally, it delivers this efficacy without the systemic side effects, such as weight gain or sexual dysfunction, often associated with standard oral treatments,” says Mansson.
Wilkinson agrees that the device could be a good option for people who want to treat their depression but don’t like the side effects of antidepressants.
Side effects and risks of the FL-100 are minimal. These included tingling at the electrode sites, brief skin irritation, or headache. Skin burns have occurred only when people reused electrodes or allowed electrode pads to dry out, which the device instructions warn against.
How Does the FL-100 Improve Depression?
As with many treatments that involve the brain, there are theories about how the device alleviates depression, but little certainty, says Wilkinson.
Depression is often linked to lowered activity in the front of the brain, an area called the prefrontal cortex which is responsible for mood regulation. In people with depression, this area is underactive.
“The FL-100 works by delivering a gentle, comfortable electrical signal to the forehead to restore healthy brain activity and reduce symptoms,” says the Flow chief medical officer, Kultar Garcha, MD, who is also a family doctor.
Dr. Garcha says that the key benefits are safety and convenience.
It avoids the common issues associated with pills, and it’s also “incredibly easy to use,” he says.
“The device is a wireless headset you wear at home for just 30 minutes while following a simple app, allowing you to get treatment without disrupting your daily routine,” he says.
Who’s a Good Fit for the New At-Home Device?
Garcha says he’s found the device is often best suited for patients earlier in their treatment journey, rather than as a last resort.
“It fits well when a patient has experienced a recent change in their condition or life, suggesting their brain is ‘primed for plasticity,’ meaning it is adaptable and ready to relearn healthy patterns,” he says.
It can also be an option for people who want to avoid medications entirely or people who are taking antidepressants but feel “stuck” and need a “boost,” says Garcha.
How Much Will the Device Cost and Will Insurance Cover It?
Flow expects the U.S. retail price of the FL-100 to be between $500 and $800. Pricing for electrode pads or potential subscription components has not yet been released.
The company is “actively engaging in discussions with a number of U.S. insurance payers and exploring various coverage pathways,” says Erin Lee, the CEO of Flow.
The goal is for the device to become broadly reimbursable for patients through commercial and other insurance plans, but that will take time, says Lee.
“As a result, it’s unlikely that broad coverage will be in place at the Q2 launch, but we remain optimistic and hope to be able to share more details early next year,” she says.
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