Flow Neuroscience’s FL-100 headset received FDA premarket approval on December 8, 2025, making it the first at-home prescription brain stimulation device cleared for major depressive disorder in the United States. The company plans to begin selling the device to US patients in the second quarter of 2026, priced between $500 and $800. A prescription will be required.
The approval came through the PMA pathway (P230024), the FDA’s most stringent review process, reserved for novel Class III devices without a predicate. That distinction matters. The FL-100 is not a consumer wellness gadget or a 510(k) clearance riding on similarity to an existing product. It went through the same regulatory gauntlet as pacemakers and cochlear implants.
The clinical evidence
The pivotal study behind the approval was a fully remote phase 2 randomized sham-controlled trial published in Nature Medicine in October 2024. It enrolled 174 adults with moderate to severe major depressive disorder: 87 received active treatment, 87 received sham stimulation. No clinic visits were required.
Participants used the headset five times per week for three weeks, then three times per week for seven weeks, each session lasting 30 minutes. The device delivers 2.0 milliamps of transcranial direct current stimulation to the dorsolateral prefrontal cortex, a brain region involved in mood regulation.
The results: 44.9 percent of the active group achieved remission at 10 weeks, compared with 21.8 percent in the sham group. Average improvement on the Hamilton Depression Rating Scale was 9.41 points for active treatment versus 7.14 for sham (P = .012). Adverse events were generally mild, mostly skin irritation at the electrode sites and occasional headaches. Discontinuation rates were similar between groups.
The indication covers moderate to severe MDD in adults who are not treatment-refractory to medication, either as a standalone therapy or alongside antidepressants.
Seven years of European data
Flow Neuroscience is not new to this. The company, founded in Malmö, Sweden, in 2016 by clinical psychologist Daniel Månsson and neuroscientist Erik Rehn, launched the FL-100 in Europe in June 2019 under CE Mark Class IIa certification. It has since accumulated tens of thousands of users across Europe and has been integrated into six NHS trusts in the United Kingdom. The company has raised $11.9 million across four rounds, with investors including Khosla Ventures and Kirin Holdings.
That European track record gives the FL-100 something most newly approved devices lack: years of real-world use data outside a clinical trial setting. It also means the company enters the US market with an established manufacturing and support infrastructure, not as a startup shipping its first units.
A second approval followed within weeks
Flow was not alone for long. In January 2026, the FDA approved Neurolief’s ProlivRx system, also via PMA, for adjunctive treatment of MDD in adults with inadequate response to at least one antidepressant. ProlivRx uses a different mechanism, targeting the occipital and trigeminal neural pathways rather than the prefrontal cortex with tDCS.
The ProlivRx trial showed a 21.3 percent remission rate versus 6.0 percent for sham (P = .027), lower than Flow’s figures but in a more treatment-resistant population. ProlivRx is a subsidiary of BrainsWay, the Israeli company that pioneered deep transcranial magnetic stimulation.
Two FDA-approved at-home neuromodulation devices for depression within six weeks of each other represents a regulatory shift. Until late 2025, the FDA had not approved any at-home brain stimulation device for depression. The at-home neuromodulation category now has a regulatory precedent that other developers, including consumer device companies, will likely try to build on.
Why it matters for BCI
Brain stimulation and brain-computer interfaces are distinct technologies, but they share regulatory infrastructure, clinical populations, and in some cases hardware. The fact that the FDA approved two non-invasive neural devices for home use through its most rigorous pathway in rapid succession signals that the agency is willing to evaluate brain-targeting technologies for everyday therapeutic settings. For BCI companies approaching the FDA with their own devices, the precedent is useful: the agency has now demonstrated that it can assess safety and efficacy for neural devices used outside clinical environments.
The broader market context is also relevant. Depression affects roughly 280 million people globally. If even a fraction of treatment-seeking patients adopt at-home neuromodulation, it creates an economic and regulatory ecosystem around consumer neural devices that benefits the entire sector.