Flow Neuroscience Gains Australian TGA Approval for At-Home Depression Treatment

The Therapeutic Goods Administration (TGA) has approved the Flow Neuroscience tDCS-based brain stimulation headset for at-home treatment of major depressive disorder. The product is now considered a class IIa medical device intended for adults (ages 18 and older).

Nearly one in five Australians experience depressive episodes. Meanwhile, waiting times for mental health services have risen more than tripled over the past decade. According to the Government Productivity Commission’s review of 2025, service delays are among the major barriers to accessing mental health and suicide prevention services in the country, together with staff shortages.

“At-home mental health treatments like Flow emerge as a way to reduce the strain on healthcare systems. They can cut the time spent at the clinic, and give patients timely relief, preventing the need for emergency care,” Flow Neuroscience CEO Erin Lee stated. “We are happy that Australians can now access this transformative depression treatment, especially in the comfort of their homes.”

Prior to its TGA approval, the Flow headset has been used by more than 50,000 users in the EU, United Kingdom, Switzerland, and Hong Kong. In the United Kingdom, it is also NHS-approved and has been prescribed by doctors within the public health system.

“With Australian doctors now able to prescribe Flow for at-home use, patients can begin treatment immediately and see the effect within weeks,” Flow Neuroscience Global Medical Director Dr. Kultar Singh Garcha said. “In comparison, antidepressants can take months to show results and may require years of trial and error. And side effects like sleep problems, weight gain or sexual dysfunction can further slow recovery.”

Flow Neuroscience has conducted a landmark study published in Nature Medicine on the device’s effectiveness. Latest data confirms that more than 70% of patients report a reduction in their depressive symptoms within three to six weeks of use. These results reveal a much better response to treatment than antidepressants, and side effects were also limited to mild tingling or itching at the electrode site.

The trial demonstrated, for the first time at scale, that a fully remote, home-based neuromodulation treatment can deliver clinic-grade results in major depression. Over 10 weeks, active tDCS not only outperformed sham stimulation but achieved two to three times higher response and remission rates, even among patients already on medication or psychotherapy, making it far closer to real-world conditions than most previous trials.

Transcranial direct current stimulation (tDCS), the non-invasive brain stimulation technology behind the device, specifically regulates activity in the prefrontal cortex, the part of the brain involved in mood regulation and stress response. It is often underactive in people with depression. “tDCS stimulates the prefrontal cortex with low electrical currents, which activate neurons’ ability to respond to signals from other neurons. This strengthens their connectivity, rebalancing the brain to a healthy state,” Dr. Garcha explained.

Flow’s usage protocol involves five or fewer 30-minute sessions per week, depending on the clinician’s recommendation. During the sessions, the device is placed on the head and turned on, allowing the process of brain stimulation to start. Sessions can be done while sitting, reading, or doing other routine activities.

“Governmental health systems all over the world find it challenging to adapt the clinical practice to rapidly rising mental health demands, but we are glad Australia is moving forward,” Lee commented. “Now TGA-approved, Flow can help clinicians extend depression care into the home, easing pressure on services without compromising the oversight.”

Flow Neuroscience is a healthcare company focused on non-drug therapies for depression. Founded in Sweden in 2016 by clinical psychologist Daniel Mansson and engineer Erik Rehn, the company launched its medical tDCS headset in Europe in 2019. Lee, a former Google, Uber, and Babylon executive, became CEO in 2022. Flow’s device is the only at-home tDCS treatment with CE certification in Europe and approval in the U.K.’s NHS.