NEWNow you can listen to Fox News articles!
For the first time, Americans with depression will be able to use a prescription brain stimulation device at home.
The approval comes from the US Food and Drug Administration and marks a major change in how mental health conditions can be treated. The newly approved device is called the FL-100, and it comes from Flow Neuroscience.
Intended for adults 18 and older with moderate to severe major depression. Doctors may prescribe it as a stand-alone treatment or in conjunction with antidepressants and therapy. This decision is important because depression affects more than 20 million adults in the US. About one-third do not get enough relief from medication or stop taking it because of side effects.
Sign up for my FREE CyberGuy report
Get my best tech tips, emergency security alerts and exclusive deals delivered straight to your inbox. Plus, you’ll get instant access to my Ultimate Scam Survival Guide – free when you join CYBERGUY.COM newspaper.
DAILY PRACTICE MAY HELP RELIEVE DEPRESSION MORE THAN MEDICATION, EXPERTS SAY
Flow Neuroscience has received approval from the US Food and Drug Administration for its FL-100 prescription brain stimulation device. (Flow Neuroscience)
How Flow FL-100 works
The FL-100 uses transcranial direct current stimulation, often abbreviated to tDCS. This technology delivers mild electrical currents to the prefrontal cortex, an area of the brain tied to emotion regulation and stress response. For many people with depression, activity in this area is reduced. By stimulating it, the device aims to restore healthy brain signaling over time. The system looks like a lightweight headset and pairs with a mobile app. Patients use it at home for about 30 minutes a day while doctors monitor progress remotely.
Clinical outcomes after approval
The FDA based its decision on a randomized controlled trial that tested home use under remote supervision. Participants who received active motivation showed meaningful improvement in both physician-rated and self-reported depression scales. After 10 weeks of treatment, patients experienced a 58 percent improvement in symptoms compared to the control group. Many users have reported significant changes within the first three weeks. The study was published in the journal Nature Medicine, adding credibility to the findings. Side effects were usually mild and temporary. Reported side effects include skin irritation, redness, headache, and a brief tingling sensation at the electrode sites.
The FDA has approved the first prescription brain stimulation device for the home treatment of depression in the US, marking a major shift in mental health care. (photo by ISSAM AHMED/AFP via Getty Images)
A growing shift toward technology-based mental health care
The Flow device has already been used by more than 55,000 people across Europe, the UK, Switzerland, and Hong Kong. In the UK, it is decided within parts of the public health system. Company leaders say the US approval opens the door to wider access to drug-free treatment options. The momentum is not isolated. By 2025, researchers at UCLA Health have developed another experimental method for brain regeneration, indicating rapid growth in the field. Together, these developments suggest that home neuromodulation may become a mainstream part of depression care instead of a fringe option.
When will the device be available
Flow expects FL-100 to be available to US patients in the second quarter of 2026. A prescription will be required, and a companion app will be available on iOS and Android. The company also plans to test additional uses for its platform, including sleep disorders, addiction, and traumatic brain injury.
10 HEALTH TECH PRODUCTS SHOWING UP AT CES 2026
Flow Neuroscience’s FL-100 headset delivers mild electrical stimulation to the brain and can be prescribed for home use under medical supervision. (Flow Neuroscience)
What you should know before trying Flow
Flow is approved by the FDA for adults 18 and older with moderate to severe major depression, and requires a prescription from a licensed healthcare provider. Doctors may recommend it on its own or alongside medication or therapy. The headset is non-invasive and designed for home use, but is not intended for emergencies or people considered resistant to treatment. It also does not replace crisis care or immediate mental health support. Most users wear the headset for about 30 minutes per session. Mild itching, warmth, itching of the skin, or headache may occur, especially early on. These effects are usually short-lived and monitored by a doctor with a corresponding application.
Couples flow through a mobile app that guides treatment and supports remote clinical supervision. Your provider sets up a treatment plan, and the device follows prescribed settings to ensure safe use. Pricing and insurance coverage may vary once the device becomes available in the US. Some patients may access Flow through clinics, research programs, or as it is widely accepted in general depression care. The bottom line is simple. Flow adds another evidence-based option, not a panacea and not a one-size-fits-all solution. For people who have struggled to find relief, having another clinically proven option can be invaluable.
What does this mean to you?
If you or someone you care about suffers from depression, this endorsement expands the range of real treatment options. It offers a non-drug method that can be used at home under medical supervision. For patients who have not responded well to medication or are experiencing unwanted side effects, this may offer another way forward. It also reflects a broader trend toward personalized, technology-enabled mental health care.
Take my questions: How secure is your internet security?
Think your devices and data are really protected? Take these quick questions to see where your digital habits stand. From passwords to Wi-Fi settings, you’ll get a personalized explanation of what you’re doing well and what needs improvement. Take my questions here: Cyberguy.com.
ELON MUSK IS PLANNING TO MANUFACTURE SEVERE BRAIN POWER FOR DISABILITY, MENTAL DISEASE.
The newly approved device targets adults with moderate to severe depression and can be used alongside medication or therapy. (Photo by Sarah Silbiger/Getty Images)
Kurt’s priority is taking
This FDA approval feels like a real revolution. For many years, brain stimulation for depression remained closed within clinics. Now it can be done at home and the doctor will guide the process. That is important for people who have tried drugs, experienced side effects, or feel stuck in limited decisions. This device won’t be the right answer for everyone, but it gives patients and doctors one tool that’s proven to work. And for many people living with depression, having another option can make a difference.
If a doctor could prescribe a brain stimulation headset instead of another pill, would you be open to trying it? Let us know by writing to us at Cyberguy.com.
CLICK HERE TO DOWNLOAD THE FOX NEWS PROGRAM
Sign up for my FREE CyberGuy report
Get my best tech tips, emergency security alerts and exclusive deals delivered straight to your inbox. Plus, you’ll get instant access to my Ultimate Scam Survival Guide – free when you join CYBERGUY.COM newspaper.
Copyright 2026 CyberGuy.com. All rights reserved.
