Flow Neuroscience Launches FL-100 At-Home Depression Headset in the US

Flow Neuroscience has launched its FL-100 headset in the United States, making the first FDA-approved at-home transcranial direct current stimulation (tDCS) treatment for depression available by prescription, according to HIT Consultant and Healio, which reported the Swedish company's announcement on September 8 and 9.

The launch comes nine months after the FDA approved the device. The agency's premarket approval database lists PMA P230024 for the Flow FL-100, filed by Flow Neuroscience AB on August 7, 2023, with a decision date of December 8, 2025. The record classifies the device under the generic name "Cranial electrotherapy stimulator to treat depression," regulation number 882.5800, product code JXK, reviewed by the neurology advisory panel. It notes that expedited review was not granted.

What the approval covers

According to the approval order statement in the FDA record, "FL-100 is intended for the treatment of moderate to severe major depressive disorder in the current episode, either as monotherapy or as an adjunctive treatment, in patients 18 years and older who are not considered treatment refractory to medication." The device is prescription-only, HIT Consultant reported.

The system pairs a wireless headset with a companion app. Healio, citing the company's release, said the headset "applies a gentle electrical current to the left dorsolateral prefrontal cortex, an area of the brain involved in functions including the regulation of emotion." The app, the company said, "guides treatment, tracks changes in symptoms over time and allows adherence and outcome data to be shared with their clinician."

HIT Consultant described the treatment schedule as 15 sessions of 30 minutes over the first three weeks, followed by three maintenance sessions a week. It reported that the software controls stimulation timing, prevents over-use and sends compliance data to the prescribing physician, and that the headset delivers currents of 0.5 to 2.0 mA.

Trial data behind the decision

The FDA record links the approval to clinical trial NCT05202119. Flow Neuroscience reported that in the pivotal trial, published in Nature Medicine in 2024, 57% of participants achieved remission at 10 weeks, Healio said. HIT Consultant identified the study as the 10-week, double-blind, sham-controlled EMPOWER trial and reported remission as a Montgomery-Åsberg Depression Rating Scale score of 12 or lower.

According to HIT Consultant, active stimulation produced two- to three-fold higher response and remission rates than sham, and adverse events were largely limited to temporary skin redness and mild tingling where the electrodes touch the skin. These figures come from the company's announcement and the published trial as summarised by the two outlets; Health Sense did not review the full trial report.

How patients will be reached

The company said it is setting up prescribing channels for psychiatrists, primary care physicians and psychiatric nurse practitioners, HIT Consultant reported. Patients can be evaluated in person or remotely through Flow Care, which the outlet described as an affiliated telemedicine pathway staffed by independent licensed clinicians. Flow is also rolling out training modules for clinicians on reading remote adherence data.

Flow said the platform has been used by more than 65,000 people in the UK, Europe and Australia, with more than 1,200 healthcare professionals prescribing it, and that it is used in multiple NHS trusts in the UK, according to HIT Consultant.

"FDA approval was a major scientific and regulatory milestone for Flow, but making the treatment available to patients is the moment that really matters," said Daniel Månsson, the company's chief executive and co-founder, as quoted by HIT Consultant. "For the first time in the US, clinicians can prescribe an FDA-approved tDCS treatment for depression that patients can use in their own homes."

Neither report gave a US price for the headset.