Brain-Zapping Device OK'd by FDA May Offer SSRI Alternative

A small headset that delivers weak electrical currents to the brain is being pitched as a new front-line weapon against depression, and a possible way to lean less on Prozac and other SSRIs. The Flow FL-100 device, from Swedish company Flow Neuroscience, received FDA clearance in December after years of use in Europe, where it can be bought over the counter for about $530, reports the New York Times. It uses transcranial direct-current stimulation, or tDCS, a far milder form of brain zapping than electroconvulsive therapy, and is designed to be used at home under remote supervision.

"This is as far from ECT as a jet engine is from my bicycle," says neuromodulation expert Dr. Mark George of the Medical University of South Carolina. The promise is big, the proof less so. The US trial that led to FDA approval found only modest improvement on a primary depression scale and "moderate" uncertainty around its benefits, partly because many participants knew whether they were getting the real treatment or not. Secondary findings were stronger: About 58% of users had some kind of response to the device, versus 38% in the control group.

Meanwhile, 45% of the device's users went into full remission, versus 22% in the control group. The FDA cleared Flow as a first-line option, not a last resort, which could push psychiatry further beyond a pill-first mindset. Still, experts stress tDCS is in its early stages—useful for some patients, and potentially helpful alongside antidepressants, but far from a proven replacement for them. Reuters previously reported that the Flow FL-100 would be available by prescription only in the second quarter of 2026. The company has said it's still coming up with pricing.