Archive · 13 Dec 2025
FDA Approves First At-Home Depression Treatment Device
The FDA has approved a new headset called FL-100 that helps treat depression at home.
It sends a gentle electric current to the part of the brain that controls mood.
This device is meant for adults with moderate to severe depression.
It's not a drug, so it doesn't have the same side effects as antidepressants.
The company that made it, Flow Neuroscience, says it's been used by over 55,000 people in other countries.
In tests, about 58% of people who used it felt much better.
It costs between $500 and $800, and you'll be able to buy it in the US starting in mid-2026.
FDA approves FL-100, the first at-home device for treating depression
Headset uses transcranial direct current stimulation to target mood-regulating brain area
Clinical trials showed 58% remission rate in participants after 10 weeks of use
Device costs between $500-$800 with no subscription fees, available in US mid-2026
Common side effects include mild skin irritation and headaches, with no serious reactions reported
- Who
- Flow Neuroscience
- What
- FDA-approved at-home depression treatment device (FL-100)
- When
- Approval announced December 12, 2025; US availability mid-2026
- Where
- United States (previously available in Europe, UK, Switzerland, Hong Kong)
- Why
- To provide a non-drug alternative for treating moderate to severe depression
- Device Name
- FL-100
- Manufacturer
- Flow Neuroscience
- Treatment Method
- Transcranial direct current stimulation
- Target Area
- Dorsolateral prefrontal cortex
- Clinical Trial Participants
- 174
- Remission Rate
- 58%
- Expected US Price
- $500 - $800
- Availability in US
- Mid-2026