FDA just approved the 1st at-home device for treating depression
Big news: The FDA has given the green light to Flow's FL-100, the first device you can use at home to treat moderate to severe depression (for adults 18+ who aren't resistant to meds).
With US depression rates up 60% in the last decade and over 20 million adults affected, this feels like a much-needed option.
The FL-100 uses gentle electrical currents to the part of the brain that regulates mood—all without leaving your room.
How it works, what it costs, and what to expect
Flow plans to launch FL-100 in the US by mid-2026 with a prescription price between $500-$800.
Over 55,000 people in Europe, the UK, Switzerland, and Hong Kong have already tried it, with about 77% seeing symptom improvement in three weeks and more than half reaching remission after 10 weeks.
Treatment usually lasts for 12 weeks; side effects are generally mild (think skin irritation, headaches, and tingling sensations at electrode sites).
Skin burns have occurred when the device's pads were reused or dried out.
Flow is working on getting insurance coverage sorted—more updates expected early 2026.