It's not a drug, and it may also have some benefits to quell overeating—here's how tech is transforming mental health care.
Depression diagnoses in the U.S. have increased by roughly 60% over the past decade, and according to the Centers for Disease Control and Prevention (CDC), roughly 11% of adults now take antidepressant medications.
Thanks to Dr. Kathleen Welsh’s team at Bay Area Body, part of our team had tried the Exomind: a clinic-based machine that generates electromagnetic pulses to the brain for the purpose of creating new neural pathways—a method that has shown some effectiveness in fending off depression symptoms and, in some cases, food cravings. Even after just two of the recommended six 25-minute sessions, our lead editor observed a consistently lifted mood and, remarkably, fewer food cravings triggered by stressed-out afternoons during the week.
Now, the effect may be within reach even if there’s not a clinic near you offering Exomind treatment. In December 2025, the U.S. Food and Drug Administration (FDA) approved the first at-home brain stimulation device designed to treat depression—marking a milestone as rates of the condition continue to climb nationwide.
The headset device, called the Flow FL-100, reportedly uses a low-level electrical current to stimulate an area of the brain involved in mood regulation. The FDA cleared it for adults ages 18 and older with moderate to severe major depressive disorder (MDD) who are not considered resistant to medication.
A report explains the device can be used on its own or alongside therapy or antidepressants. While it is not the first brain-stimulating procedure to target depression—the Mayo Clinic points out that transcranial magnetic stimulation (TMS), for example, has existed since the mid-1980s—this therapy is the first designed for at-home use with remote clinical oversight.
According to FDA records, the Flow FL-100 was initially granted “breakthrough device status” in 2022, based on a reasonable expectation that “availability would be in the best interest of patients if the device is effective.” However, the FDA also notes “a moderate level of uncertainty of benefit” even now, following its approval.
The final FDA authorization was based on results from a mid-stage clinical study showing that 58% of U.S. participants experienced remission after 10 weeks of treatment, Reuters reports. Notably, many of those patients were already taking medication or attending therapy.
Outside the U.S., the company reports that about three-quarters of users noticed symptom improvement within three weeks. Flow Neuroscience says its device has already been used by more than 55,000 people across Europe, the U.K., Switzerland, and Hong Kong.
Treatment follows a structured 12-week plan. Patients begin with five 30-minute sessions per week for the first three weeks, then reduce to two or three weekly sessions for the remaining nine weeks. Reported side effects tend to be mild and short-lived, including headaches, skin irritation, or tingling where electrodes are placed. Improper pad use—such as reusing or allowing them to dry out—has been linked to skin burns.
Flow plans to introduce the prescription-only device in the U.S. in the second quarter of 2026, with an expected price range of $500 to $800. The company is also in talks with insurers, with potential coverage announcements anticipated in early 2026.
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