Flow headset offers non-drug option that may ease disability and drug cost pressures in depression care
A first-of-its-kind at-home brain stimulation headset for depression has cleared the toughest US medical device approval pathway, positioning it as a potential non-drug option for patients who can use it at home.
According to Reuters, the US Food and Drug Administration approved Flow Neuroscience’s FL-100 headset to treat moderate to severe major depressive disorder in adults aged 18 and older who are not considered resistant to medication.
The device can be used on its own or alongside other treatments and will be available in the US only by prescription.
BNN Bloomberg reports that the FDA granted approval through its “premarket approval” process, described by Flow Chief Executive Officer Erin Lee as “the most stringent pathway for medical devices.”
Lee said the company chose this more demanding route, even after the agency had floated a less strict procedure, to strengthen public confidence in the device’s safety and effectiveness.
The FL-100 uses transcranial direct current stimulation, directing electrical energy into the head from outside the skull, with two pads resting on the forehead to deliver a gentle current to the part of the brain that regulates mood, Reuters report.
Patients typically follow a 12-week course, starting with five sessions per week for three weeks and then two or three sessions weekly for the remaining nine weeks, with each session lasting 30 minutes.
Reuters said the FDA based its decision on a mid-stage study in which 58 percent of patients achieved remission after 10 weeks, including many already on medication or in therapy.
Flow also told Reuters that among global users, 77 percent reported symptom improvement within three weeks.
Bloomberg reports that in a separate study used for approval, patients who used the active device saw a greater reduction in depressive symptoms than those using a modified version without ongoing electrical stimulation, with differences emerging as early as four weeks.
Side effects are generally mild and temporary, including skin irritation, headache and tingling at electrode sites, although the company said skin burns have occurred when users reused or allowed the pads to dry out.
Flow plans to introduce the device in the US in 2026 as a prescription-only treatment, with Reuters reporting a targeted retail price between US$500 and US$800.
Lee told Reuters the company is negotiating with insurance payers and expects to announce coverage partnerships in early 2026.
Bloomberg reports that US patients will make a one-time purchase for the headset, with no subscription or maintenance fees, although they will need replacement pads.
According to Reuters, more than 55,000 people have already used the device in Europe, the UK, Switzerland and Hong Kong, where it has been available since 2020.
Bloomberg reports that Flow plans further trials in conditions including bipolar disorder, traumatic brain injury, pain and addiction, and is developing a new version of the device that will also detect brain activity so stimulation can be customised.
