The U.S. Food and Drug Administration has cleared an at-home brain stimulation headset developed by Flow Neuroscience to help treat depression, giving patients another option beyond standard antidepressant drugs, which many people struggle to stay on because of long-term side effects, the company announced on Thursday.

Rates of depression in the U.S. have climbed sharply, rising by about 60% over the past ten years and now affecting more than 20 million adults, according to data from the Centers for Disease Control and Prevention.

FDA Approves First At-Home Brain Stimulation Device For Treatment of Depression

The US Food and Drug Administration (FDA) has approved a home-use brain stimulation device designed to treat major depressive disorder in adults. The device, known as FL-100 and made by Flow Neuroscience, is the first at-home treatment of its kind to receive approval in the United States.

The FDA’s decision was supported by results from the Empower phase 2 clinical trial, which found that 58% of participants reached remission after 10 weeks of treatment. Flow Neuroscience also reported that among users worldwide, 77% noticed an improvement in symptoms within three weeks. To date, more than 55,000 patients have used the device in regions including Europe, the UK, Switzerland, and Hong Kong.

Brain Stimulation Device For Depression: How Will The Headset Work?

The prescription device, called FL-100, uses transcranial direct current stimulation to send a mild electrical current to the brain’s prefrontal cortex, an area involved in mood control and stress response. According to Flow, this part of the brain is often less active in people living with depression, a condition that affects over 20 million adults across the U.S.

Flow noted that roughly one in three people with depression does not respond adequately to antidepressant medications, and many others discontinue them because of unwanted side effects.

“Flow’s FDA approval marks a turning point in depression care, representing the first real move away from medication-only treatment toward technology-based therapies with fewer side effects,” said Flow CEO Erin Lee in a statement.

During the study, participants wore the headset for 30 minutes per session while resting, beginning with five sessions a week for the first three weeks, then reducing to three sessions per week for the rest of the trial. The program also included live remote monitoring through video calls.

Researchers observed benefits in patients who were already taking antidepressants for treatment-resistant depression or receiving psychotherapy, as well as in those who were not using medication at all.

“Among people using Flow in real-world settings, 77% report feeling better in as little as three weeks,” said Kultar Garcha, M.D., chief medical officer at Flow. “A treatment that was once limited to clinics can now be used at home, offering a practical way to widen access to effective depression care.”

Flow said it plans to launch the headset commercially in the U.S. in the second quarter of next year and intends to explore its potential use for conditions such as traumatic brain injury, addiction, and sleep disorders.

“We want Flow to become part of the standard pathway for treating depression,” Lee said. “Our focus is clear: to help as many people as possible reach remission and regain their quality of life.”

Three children from Ottawa and Eastern Ontario have died due to flu-related complications over the past two weeks, as an unusually early and aggressive flu season grips the region. Health officials have confirmed that the cases are linked to Influenza A, a strain currently circulating widely and affecting children more severely than usual, as per CTV news.

The children were between five and nine years old. Authorities have not released further personal details about the two Ottawa cases and one case from Eastern Ontario.

What Is Influenza A?

Influenza A is a fast-spreading respiratory virus responsible for seasonal flu outbreaks and, at times, global pandemics. It changes quickly through genetic shifts, which makes new strains harder to predict and control. The virus is grouped based on surface proteins called hemagglutinin and neuraminidase, with H1N1 and H3N2 among the most common strains in circulation. It spreads mainly through coughs, sneezes, or close contact and often comes on suddenly, causing fever, cough, body pain, and extreme tiredness. In some cases, it can lead to serious complications, especially in vulnerable groups.

Influenza A: Health Officials Call Deaths a Serious Warning

Public health leaders from Ottawa and Eastern Ontario described the deaths as a troubling reminder of how dangerous the flu can be, especially for children.

“This highlights that influenza is not always a mild illness. It can lead to serious complications that require hospitalization,” medical officers of health from both regions said in a joint statement issued on Monday, as per CTV News.

Influenza A: Child Flu Deaths Rare but Not Unprecedented in Canada

While flu-related deaths among children are uncommon in Canada, they are not unheard of. During the last severe flu season in 2022, two children in Ottawa died due to influenza.

Most flu-related deaths in Canada occur among older adults. Of the estimated 3,500 flu deaths reported nationwide each year, roughly 90 percent involve people over the age of 65. However, experts say the current Influenza A strain is behaving differently.

Influenza A Hitting Children Hard This Season

The strain of Influenza A currently circulating has been linked to a sharp rise in severe pediatric flu cases globally. Health officials say the cluster of three child deaths within such a short period, and within a relatively small geographic area, is highly unusual.

This unusual pattern prompted the regional coroner to alert public health authorities after three sudden, unexpected child deaths tested positive for Influenza A.

“It’s rare for the coroner to reach out like this,” said Dr. Trevor Arnason, Ottawa’s medical officer of health. “But this season has been particularly severe.”

Influenza A: Hospitals Strained as Pediatric Cases Rise

CHEO, Ottawa’s children’s hospital, has reported high numbers of children falling seriously ill with the flu since November. Hospitalizations have continued to rise through early December.

Last week, CHEO issued an urgent request asking family doctors to extend clinic hours and assist at the hospital’s Kids Come First clinic to help manage patient volumes.

Hospital officials have also noted that many children arriving at the emergency department with severe flu symptoms had not been vaccinated.

Influenza A: Strong Push for Flu Vaccination as Cases Surge

Public health officials, including Ontario’s Chief Medical Officer of Health Dr. Kieran Moore, are urging everyone aged six months and older to get vaccinated as soon as possible.

Dr. Arnason and Dr. Paul Roumeliotis, medical officer of health and CEO of the Eastern Ontario Health Unit, stressed that vaccination is especially important for children this season.

Influenza A: Vaccine Still Effective Despite Strain Mutation

Some people have expressed concern after reports suggested this year’s flu vaccine is not a perfect match for the circulating Influenza A strain. Health officials clarified that while the virus has mutated slightly since circulating in the southern hemisphere, the vaccine still offers meaningful protection.

“The flu vaccine may not always prevent infection, but it significantly reduces the risk of severe illness, hospitalization, and complications,” officials said. They added that the vaccine takes about two weeks to become fully effective, making early vaccination crucial ahead of the holiday season, when virus spread typically increases.

There has been a long-running belief that COVID-19 vaccines are behind sudden deaths in young adults. Posts circulating on social media and unverified online claims have repeatedly linked vaccination to sudden collapses, heart attacks, or unexpected deaths, particularly among people aged 18 to 45 who seemed otherwise healthy.

These claims have caused anxiety among families, despite the absence of solid scientific backing. A new study published by AIIMS now brings much-needed clarity on whether COVID vaccines have any connection to sudden deaths in young adults.

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AIIMS Study Finds No Link Between Covid Vaccination And Sudden Deaths In Adults

Worries around sudden deaths in young adults have increased in recent years, especially in the period following the COVID-19 pandemic. Speculation blaming COVID vaccines gained traction across platforms, adding to public concern. However, fresh findings from a study carried out by the All India Institute of Medical Sciences (AIIMS), New Delhi, offer a clear answer. After examining detailed autopsy reports, researchers concluded that underlying heart disease, and not COVID-19 vaccination, is the leading cause of sudden deaths in younger individuals.

Heart Problems Leading Cause Among Deaths In Young People

The AIIMS study found that heart-related conditions were responsible for 42.6 per cent of sudden deaths among people aged 18 to 45 years. Within this group, heart attacks accounted for nearly 85 per cent of cardiac-related deaths. Other contributing factors included structural abnormalities of the heart, congenital defects, and inflammation of the heart muscle. Respiratory illnesses made up around 21.3 per cent of sudden deaths, with choking, pneumonia, and tuberculosis emerging as the main causes. In close to one-fifth of the cases, doctors were unable to determine the exact cause of death.

No Evidence Linking Deaths To Covid Or Vaccines

Crucially, the researchers observed no meaningful rise in sudden deaths among individuals who had previously contracted COVID-19 or received the vaccine. Of the cases analysed, only 4.3 per cent had a history of COVID infection, while 82.8 per cent had been vaccinated. Dr Sudheer Arava, Professor of Pathology at AIIMS, explained that the year-long study reviewed nearly 100 cases and found no signs of vaccine-related complications, with just one instance of myocarditis reported. The findings also pointed to differences across age groups.

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Among those aged 46 to 65, nearly three-quarters of sudden deaths were linked to heart disease, while unexplained deaths were far fewer. Notably, the proportion of women among sudden deaths was higher in the younger age group than among older adults. The study carries weight as it directly challenges claims blaming COVID-19 vaccines for sudden deaths.

Doctors emphasise that lifestyle-related issues such as unhealthy eating habits, lack of physical activity, and chronic stress continue to play a major role in heart disease among younger people. This, they say, highlights the importance of early prevention and regular health screenings. Dr Arava also urged the public to rely on credible scientific information and steer clear of misinformation that could erode trust in proven public health measures, including vaccination.