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FDA clears first at-home brain device for depression

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FDA clears first at-home brain device for depression

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For the first time, Americans with depression will soon be able to use a prescription brain-stimulation device at home. 

The approval comes from the U.S. Food and Drug Administration and marks a major shift in how mental health conditions may be treated. The newly approved device is called FL-100, and it comes from Flow Neuroscience. 

It is designed for adults 18 and older with moderate to severe major depressive disorder. Clinicians can prescribe it as a stand-alone treatment or alongside antidepressants and therapy. This decision matters because depression affects more than 20 million adults in the U.S. Roughly one-third do not get enough relief from medication or stop taking it due to side effects.

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SIMPLE DAILY HABIT MAY HELP EASE DEPRESSION MORE THAN MEDICATION, RESEARCHERS SAY

Flow Neuroscience has gotten approval from the U.S. Food and Drug Administration for its FL-100 prescription brain-stimulation device. (Flow Neuroscience)

How the Flow FL-100 works

The FL-100 uses transcranial direct current stimulation, often shortened to tDCS. This technology delivers a gentle electrical current to the prefrontal cortex, a region of the brain tied to mood regulation and stress response. In many people with depression, activity in this area is reduced. By stimulating it, the device aims to restore healthier 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 per day while clinicians monitor progress remotely.

The clinical results behind the approval

The FDA based its decision on a randomized controlled trial that evaluated home use under remote supervision. Participants who received active stimulation showed meaningful improvement on clinician-rated and self-reported depression scales. After 10 weeks of treatment, patients experienced an average symptom improvement of 58% compared to a control group. Many users reported noticeable changes within the first three weeks. The study was published in the journal Nature Medicine, adding credibility to the findings. Side effects were generally mild and short-term. Reported issues included skin irritation, redness, headaches, and brief stinging sensations at the electrode sites.

The FDA has approved the first prescription brain-stimulation device for at-home treatment of depression in the U.S., marking a major shift in mental healthcare. (hoto by ISSAM AHMED/AFP via Getty Images)

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A growing shift toward tech-based mental health care

Flow’s device has already been used by more than 55,000 people across Europe, the U.K., Switzerland and Hong Kong. In the U.K., it is prescribed within parts of the public health system. Company leaders say the U.S. approval opens the door for broader access to non-drug treatment options. The momentum is not isolated. In 2025, researchers at UCLA Health developed another experimental brain-stimulation approach, signaling rapid growth in this field. Together, these advances suggest that at-home neuromodulation may soon become a standard part of depression care rather than a fringe option.

When will the device be available

Flow expects the FL-100 to be available to U.S. patients in the second quarter of 2026. A prescription will be required, and the companion app will be available on iOS and Android. The company also plans to explore additional uses for its platform, including sleep disorders, addiction, and traumatic brain injury.

10 HEALTH TECH PRODUCTS STEALING THE SPOTLIGHT 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 to know before trying Flow

Flow is FDA approved for adults 18 and older with moderate to severe major depressive disorder, and it requires a prescription from a licensed healthcare provider. Doctors can recommend it on its own or alongside medication or therapy. The headset is non-invasive and designed for home use, but it is not meant for emergency situations or people considered treatment resistant. It also does not replace crisis care or immediate mental health support. Most users wear the headset for about 30 minutes per session. Mild tingling, warmth, skin irritation or headaches can happen, especially early on. These effects are usually short-lived and monitored by a clinician through the companion app.

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Flow pairs with a mobile app that guides treatment and supports remote clinical oversight. Your provider sets the 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 U.S. Some patients may access Flow through clinics, research programs, or as it becomes more widely adopted in routine depression care. The bottom line is simple. Flow adds another evidence-based option, not a cure and not a one-size-fits-all solution. For people who have struggled to find relief, having another clinically proven choice can matter a lot.

What this means to you

If you or someone you care about struggles with depression, this approval expands the range of real treatment options. It offers a non-drug path that can be used at home under medical guidance. For patients who have not responded well to medication or who experience unwanted side effects, this could provide another way forward. It also reflects a broader trend toward personalized, tech-enabled mental healthcare. 

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ELON MUSK SHARES PLAN TO MASS-PRODUCE BRAIN IMPLANTS FOR PARALYSIS, NEUROLOGICAL DISEASE

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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 key takeaways

This FDA approval feels like a real turning point. For years, brain stimulation for depression stayed locked inside clinics. Now it can happen at home with a doctor still guiding the process. That matters for people who have tried medications, dealt with side effects or felt stuck with limited options. This device will not be the right answer for everyone, but it gives patients and doctors one more proven tool to work with. And for many people living with depression, having another option could make all the 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.

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Technology

Android 17’s new foldable gaming mode could make flippy phones more fun

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Android 17’s new foldable gaming mode could make flippy phones more fun

Android 17 is getting a dedicated gaming mode for foldables that will put a virtual gamepad with touch controls on half of your screen to theoretically make it easier to play games.

With foldable gaming mode, which is set to launch in the coming months, the virtual controller emulates physical button presses at a system level and is designed to work “with any game that supports physical controllers,” says Google’s Mishaal Rahman on Reddit. For the actual inputs, the virtual controller will have a D-pad; left and right virtual sticks; A, B, X, and Y buttons; L1, L2, L3; R1, R2, and R3; and a start button. And you’ll be able to configure the gamepad in several ways, such as keeping the virtual joysticks inline or staggered from each other, scaling the size of the buttons, and toggling haptics on or off.

Turning on the mode “is as simple as unfolding your device, either before or after launching a compatible game,” Rahman says. You can also choose to hide the gamepad, and if you connect a physical controller, the virtual gamepad will turn off on its own.

“Android allows you to play a wide variety of games on the go,” says Rahman. “While touch controls work incredibly well for many titles, certain games are better enjoyed with physical gamepads. The problem is that carrying a Bluetooth controller or a snap-on gamepad with you everywhere isn’t always convenient. We want to bridge that gap, and we’re addressing it with a new feature in the Android 17 platform release that’s specifically tailored for foldable devices.”

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Debt collection letter for debt you don’t owe? What to do now

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Debt collection letter for debt you don’t owe? What to do now

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A letter arrives about a debt you don’t remember, from a company you’ve never dealt with, for an account you never opened. For a growing number of people, that notice is how they first learn someone used their identity.

Complaints to the Consumer Financial Protection Bureau (CFPB) about attempts to collect a debt not owed rose about 115% above their prior two-year average in 2025, and many of those consumers reported balances they didn’t recognize and suspected identity theft.

Before you panic or pay, it helps to understand why these letters show up and what rights you have.

WHY LAST YEAR’S BREACH IS THIS YEAR’S IDENTITY FRAUD

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A collection letter for a debt you do not recognize can be the first sign that someone used your identity. (John Carl D’Annibale /Albany Times Union via Getty Images)

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Why debt collectors contact you about a debt you do not owe

When a charged-off account is sold to a collection agency, the agency receives the original creditor’s application file, including whatever identifiers were used to open it. That contact information is often 90 to 180 days out of date by the time the account changes hands.

HOW SCAMMERS BUILD A PROFILE ON YOU USING DATA BROKERS

Before the first call, the agency runs skip tracing: matching a name, Social Security number (SSN) and past addresses against public records, postal change-of-address data, property and utility records and data-broker files to find the current person behind the account. At bulk volume, each lookup costs the agency pennies.

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The agency then contacts you directly, by phone or mail, whether or not you have looked at your credit file.

How fake debt can start with identity theft

The account behind the notice may have been opened with your information pulled from breaches and resold, then approved by an automated check that matched the data to an existing file without confirming that the applicant was you. Opening a new account is the leading form of attempted identity misuse reported to the Identity Theft Resource Center (ITRC), which counted it more often than takeovers of accounts people already held. What happens after is less understood.

10 SIGNS YOUR PERSONAL DATA IS BEING SOLD ONLINE

Charged-off debts, including fraudulent ones, are sold in bulk portfolios for pennies on the dollar, often with thin supporting paperwork. One fraudulent balance can be sold and resold across several agencies. A debt you dispute and clear with one collector can be repackaged and reappear with another months later.

With medical debt, a bill can sometimes move toward collections before you see every explanation of benefits, insurance update or corrected statement. That is why you should contact the provider and your insurer before paying a collector.

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What debt collectors legally have to tell you

Federal law gives you a defined response, and the clock starts at first contact. Under the CFPB’s Regulation F, a collector must send a validation notice describing the debt and your rights in, or within five days of, its first communication with you.

5 MYTHS ABOUT IDENTITY THEFT THAT PUT YOUR DATA AT RISK

You have 30 days from receiving that notice to dispute the debt in writing under the Fair Debt Collection Practices Act (FDCPA). Dispute inside that window, and the collector must stop collecting until it verifies the debt.

One important note: the FDCPA generally covers third-party debt collectors, not every original creditor. However, credit reporting laws, identity theft protections and state laws may still give you rights.

If the debt came from identity theft, send the collector an FTC Identity Theft Report from IdentityTheft.gov. Also, tell the collector in writing that you dispute the debt, that it resulted from identity theft and that you want it to stop reporting the account to the credit bureaus.

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IS YOUR SOCIAL SECURITY NUMBER AT RISK? SIGNS SOMEONE MIGHT BE STEALING IT

Ask Equifax, Experian and TransUnion for a block under Section 605B of the Fair Credit Reporting Act (FCRA).

With a valid identity theft report and proof of your identity, the bureaus must block the fraudulent item within four business days. A block is harder to reverse than an ordinary dispute, which counts when the same debt can be resold.

The CFPB has said it may expand the meaning of identity theft under Regulation V to cover “coerced debt,” money run up in someone’s name without their consent, including in domestic and elder abuse cases.

What to do before you pay a debt collector

Before you send money or confirm any personal details, slow down and make the collector prove the debt belongs to you.

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1) Ask for proof in writing

Do not pay, promise to pay or give out more personal information during the first call. Ask for the validation notice in writing and save every letter, voicemail and call log. Then send a written dispute within 30 days.

Fake debts can start with stolen personal information and then move from one collection agency to another. (PixelsEffect/Getty Images)

 

2) File an identity theft report if the debt looks fake

If you believe identity theft caused the account, create an FTC Identity Theft Report at IdentityTheft.gov. Send copies to the collector, the original creditor and all three credit bureaus. Also, place a fraud alert or credit freeze with Equifax, Experian and TransUnion, so it becomes harder for someone to open another account in your name.

3) Check medical bills before paying a collector

With medical debt, contact the provider and your insurer before paying a collector. Ask for an itemized bill and an explanation of benefits. A medical bill can end up in collections while paperwork, insurance reviews or billing disputes are still catching up.

4) Respond quickly if a collector sues you

If a collector sues you, do not ignore the papers. Respond by the court deadline or contact a consumer law attorney or legal aid group. Even a debt you do not owe can create bigger problems if you miss a court deadline.

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Why early fraud alerts can save you money

Once a fraudulent account charges off and sells, cleanup gets harder. You may need to dispute the debt with the collector, the original lender and all three credit bureaus. If someone resells the debt, the same problem can come back months later.

YOU HAVE A CREDIT FREEZE. IT STILL ISN’T ENOUGH

Credit monitoring can help you spot a new account or hard inquiry before the debt reaches collections. That gives you time to contact the lender, dispute the account and freeze your credit sooner.

No service can prevent every account opened in your name. However, three-bureau credit monitoring can alert you when lenders report new accounts or hard inquiries. That can help you act before a collections notice arrives or a lender denies you credit.

See my tips and best picks on Best Identity Theft Protection at CyberGuy.com.

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Kurt’s key takeaways

A collection letter for an unfamiliar debt deserves a closer look. It may mean someone opened an account in your name. Do not pay just to stop the calls. Ask for written validation and dispute the debt fast. If someone misused your information, file an FTC Identity Theft Report. Then freeze your credit and check all three credit reports. Early alerts can help you catch fraud before collections begin. That can save you money, time and stress.

Have you ever gotten a collection letter or call for a debt you knew you did not owe, and what did you do first? Let us know by writing to us at CyberGuy.com.

Before paying a collector, ask for written proof, dispute the debt and file an FTC Identity Theft Report if fraud is involved. (Daniel de la Hoz/Getty Images)

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Here’s a bunch of Prime Day deals on keyboards, mice, and other peripherals we like

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Here’s a bunch of Prime Day deals on keyboards, mice, and other peripherals we like

RAMageddon has come for computers. The price of memory chips, hard drives, and solid state storage has skyrocketed. That’s led to price increases on desktop and laptop RAM, SSDs, spinning hard drives, and pretty much everything that uses any of those things. Consoles are more expensive. Desktops are more expensive. Laptops are more expensive. Tablets and phones are more expensive. Even MacBooks, which started out expensive but then started looking like a pretty good deal, just got more expensive.

All that sucks. But if (if) there’s a silver lining, it’s that most of the stuff you plug into a computer — keyboards, mice, webcams, monitors, and so forth — isn’t getting bananas expensive. Actually, there are some good deals out there.

Great keyboards on the cheap

Hot deals on mice in your area

Monitors to watch (get it?)

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Cases and stands, hubs and docks, and other stuff

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