Overview
- FDA cleared Flow Neuroscience’s FL-100 for adults 18 and older with moderate to severe major depressive disorder who are not treatment-resistant, either as a standalone therapy or alongside other treatments.
- Approval was supported by a phase 2 trial of 174 participants showing greater symptom reduction versus sham, with about 58% achieving remission after 10 weeks.
- The device delivers transcranial direct current stimulation in 30-minute sessions over a 10–12 week regimen and is designed for home use under remote supervision.
- The FDA described the benefit as modest yet sufficient to outweigh probable risks, with reported side effects typically limited to temporary skin irritation, tingling and headaches; burns have occurred when pads were reused or dried out.
- The prescription-only headset has more than 55,000 users in Europe and other markets, and U.S. distribution is expected to include telehealth prescribers as insurers evaluate coverage.