FL-100 headset: a new home medical device for treating depression through electrical brain stimulation.

### Flow Neuroscience Launches FL-100 in the U.S.

Swedish company Flow Neuroscience has launched the FL-100 headset in the United States, offering a home treatment option for adults suffering from moderate to severe major depressive disorder. The device received pre-market approval from the U.S. Food and Drug Administration (FDA) under PMA P230024, making it a prescription device that allows for remote patient monitoring.

### Non-Pharmacological Treatment Technology

The device utilizes transcranial direct current stimulation (tDCS) technology. This method applies a low electrical current to stimulate the left dorsolateral prefrontal cortex, a brain area linked to mood regulation and cognitive functions.

The headset connects to a smartphone application that adjusts the current intensity between 0.5 and 2 milliamps. It organizes treatment session schedules, prevents overuse, and automatically sends patient compliance data to the treating physician.

### Specific Treatment Program

The treatment program includes:
– 15 sessions, each lasting 30 minutes over three weeks
– Followed by three sessions weekly for preventive care
– Symptom monitoring through approved clinical scales
– Remote medical follow-up via the Flow Care network

### Encouraging Clinical Results

The headset is based on the EMPOWER trial published in Nature Medicine, which demonstrated:
– 57% of patients achieved full clinical recovery
– 63% experienced a reduction in symptoms by 50% or more
– Side effects were mild and temporary, such as skin redness or slight tingling

### Wide Adoption Before U.S. Market Entry

The company reports that its technology has been used by over 65,000 individuals in Europe, the United Kingdom, and Australia, with the involvement of 1,200 healthcare professionals. With the FL-100 entering the U.S. market, psychiatrists and primary care doctors can prescribe the device and provide remote medical assessments.

### Device Cost

The expected cost for the device and treatment ranges between 500 and 800 dollars, as insurance coverage for this type of therapy remains incomplete.

### A New Step in Home Neuromodulation Therapy

The launch of the FL-100 marks a significant expansion in the market for medically regulated home brain stimulation devices, allowing for depression treatment outside clinical settings while maintaining remote medical oversight.

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