Overview
- The FDA granted premarket approval to Flow Neuroscience’s FL-100, the first home-use transcranial direct current stimulation headset cleared in the U.S. to treat depression.
- The prescription device is indicated for adults 18 and older with moderate to severe major depressive disorder, usable alone or alongside other therapies for patients not considered medication‑resistant.
- Regulators reviewed a mid‑stage trial showing 58% remission at 10 weeks, and the FDA characterized the benefit as modest but sufficient to outweigh probable risks such as headaches and skin irritation.
- The headset delivers tDCS via two forehead pads in 30‑minute sessions several times a week over a typical 12‑week course with an initial five‑sessions‑per‑week ramp, under remote supervision.
- Flow plans a U.S. rollout in 2026 by prescription at an estimated $500–$800 with insurer and telehealth partnerships under negotiation, citing more than 55,000 users to date in Europe and select markets.