Brain-Zapping Device OK'd by FDA May Offer SSRI Alternative
Newser • • health
Key Points:
- The Flow FL-100, a small headset delivering weak electrical currents to the brain using transcranial direct-current stimulation (tDCS), has been FDA-cleared as a new treatment option for depression, aiming to reduce reliance on SSRIs like Prozac.
- The device, developed by Swedish company Flow Neuroscience, has been available in Europe over the counter for about $530 and is designed for at-home use under remote supervision.
- Clinical trials showed modest improvement on primary depression scales with some uncertainty, but secondary outcomes revealed that 58% of users responded to treatment and 45% achieved full remission, compared to 38% and 22% in control groups, respectively.
- The FDA approved Flow as a first-line treatment option, potentially shifting psychiatry away from a pill-first approach, though experts caution that tDCS is still early in development and not a proven replacement for antidepressants.
- The device is expected to be available by prescription in the U.S. by the second quarter of 2026, with pricing yet to be finalized.
