Depression sufferers can use a futuristic headset to get treatment at home.
The Flow FL-100 is the first-ever at-home brain stimulation device and is already being used in the UK.
More than 55,000 patients use it in this country and across Europe.
Flow Neuroscience, a Scandinavian health-tech company, announced that the device has been given the green light by the Food and Drug Administration in the US, too.
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More than 20 million US adults are affected by depression, a staggering 60% rise in just 10 years, and about a third fail to respond to antidepressant medication.
Many more abandon drug treatments due to weight gain, emotional numbness, sexual dysfunction, and other common side effects.
The Flow device uses tDCS, a gentle electrical current applied to the prefrontal cortex, the region of the brain involved in mood regulation and stress response.
This area is often underactive in people with depression, as reported by Need To Know.
Flow’s trial was the largest ever conducted on home-based brain stimulation and showed for the first time at scale that a fully remote neuromodulation treatment can genuinely lift people out of major depression.
Patients using the FL-100 device saw dramatically better results than those given a sham treatment, with remission and response rates two to three times higher.
By the end of the 10-week programme, an astonishing 58% were in full remission.
And it wasn’t just those relying on the device alone.
Patients who used FL-100 alongside their usual antidepressants or therapy also improved.
tDCS has been researched for over 25 years, with more than 9,000 scientific publications examining its use in depression, stroke, pain, and other neurological conditions.
“We’re on a mission to make effective, affordable non-drug treatment available to the millions of Americans suffering from depression,” said Erin Lee, CEO of Flow Neuroscience.
“Flow’s FDA approval is a watershed moment for the treatment of depression: the first step in moving from pharmaceutical treatments to tech-based therapies with minimal side effects.”
Flow’s Chief Medical Officer, Dr Kultar Garcha, said: “Among our real-world users, 77% see improvements in as little as three weeks.
“Such treatment, previously confined to clinics, can now be delivered at home, pointing to a scalable way of expanding access to effective depression care.”
Daniel Månsson, co-founder and Chief Scientific Officer of Flow Neuroscience, added: “For more than six years since the device’s launch in Europe, we’ve been building an evidence base globally with clinical trials, peer-reviewed research, and real-world case reports.
“The approval of FL-100 in the US will now offer millions of patients an accessible and effective non-drug treatment option.”
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