FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts (2024)

FDA News Release

For Immediate Release:


Today, the U.S. Food and Drug Administration authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts. The non-invasive device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts. The device may reduce the occurrence of specific changes in the brain that are associated with brain injury.

“Today’s action provides an additional piece of protective equipment athletes can wear when playing sports to help protect their brains from the effects of repetitive head impacts while still wearing the personal protective equipment associated with the sport,” said Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.

Traumatic brain injury (TBI) can be caused by a forceful bump, blow, or jolt to the head or body, or from an object that pierces the skull and enters the brain. Not all blows or jolts to the head result in a TBI. According to the Centers for Disease Control and Prevention, from 2006 to 2014, the number of TBI-related emergency department visits, hospitalizations, and deaths increased by 53%. Blunt trauma accidents, or accidents that involve being struck by or against an object, particularly sports-related injuries, are a major cause of TBI. The National Institute of Neurological Disorders and Stroke notes that anywhere from 1.6 million to 3.8 million sports- and recreation-related TBIs are estimated to occur in the United States annually.

When worn around the neck during sports activities, the Q-Collar provides compressive force to the internal jugular veins, which in turn increases the blood volume in the skull’s blood vessels. Typically, when people experience blunt trauma accidents, the brain moves unrestrained in the skull, which is known as a “slosh.” The Q-Collar’s increase in blood volume in those blood vessels creates a tighter fit of the brain inside the skull and reduces the “slosh” movement. By reducing the movement of the brain within the cranial space, the Q-Collar may aid in the protection of the brain from the effects of head impacts.

The FDA assessed the safety and effectiveness of the Q-Collar through several studies, including a prospective, longitudinal study in the United States with 284 subjects 13 years or older who were participants on a high school football team. During the sports season, 139 athletes wore the Q-Collar and 145 athletes did not. All participants also wore an accelerometer device that measured every impact to the head sustained during play. Each athlete underwent a magnetic resonance imaging (MRI) scan pre-season and post-season. These MRI scans were used to generate Diffusion Tensor Imaging (a specialized MRI image) of the brain that allowed researchers to compare structural changes in the participants’ brain, after a season of play.

Significant changes were found in deeper tissues of the brain involved in the transmission of electrical nerve signals (white matter regions) in 106 of the 145 (73%) participants in the no-Collar group, while no significant changes in these regions were found in 107 of the 139 (77%) of the group who wore the Q Collar. These differences appear to indicate protection of the brain associated with device use. No significant adverse events were associated with device use.

The Q-Collar does not replace, and should be worn with, other protective sports equipment associated with specific sports activities, such as helmets and shoulder pads. Wearers of the device should not depend on the device to protect them from all harmful effects of head impacts. Users should take steps to avoid direct impact to the head and neck. Data do not demonstrate that the device can prevent concussion or serious head injury. The Q-Collar should not be used if an individual has not been medically cleared to play contact sports.

The Q-Collar has not been tested and should not be used on athletes with the following conditions:

  • Increased pressure in the skull (including uncontrolled ocular-glaucoma)
  • Increased presence of acid in the body or excessive blood alkalinity
  • Open head injury (including in or around the eye) within the past six months
  • Pseudotumor cerebri (false brain tumor)
  • Presence of brain or spinal shunt
  • Accumulation of cerebrospinal fluid within the brain
  • Known seizure disorder
  • Known trachea abnormality
  • Known airway obstruction
  • Known carotid hypersensitivity
  • Blood clot in the brain
  • Increased likelihood of blood clotting (coagulation)
  • Collections of small blood vessels in the brain that are enlarged and irregular in structure
  • Skin injury, rash, or other abnormality on or around the neck

The device can be worn for up to four hours at a time and should be replaced after two years of active use or upon the product’s expiration date listed on the package, whichever comes first. The Q-Collar is intended for over-the-counter use and will be distributed directly to consumers. However, a medical professional should be consulted if a user is unsure whether the Q-Collar is right for him or her.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Q-Collar to Q30 Sports Science, LLC.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts (2024)


FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts? ›

Known as a Q-Collar, the device is intended to protect athletes' brains during head impacts. The Food and Drug Administration authorized the marketing of Q30 Innovations' Q-Collars in 2021, saying they “may reduce the occurrence of specific changes in the brain that are associated with brain injury.”

Which FDA authorizes marketing of novel device to help protect athletes brains during head impacts? ›

FDA-Cleared FDA-Cleared reflects the highest level of review and authorization by the FDA for a non-invasive, low-risk device like the Q-Collar. The Q-Collar helps protect the brain from the damage caused by repetitive head impacts that can alter brain tissue.

Does the Q-Collar actually work? ›

Because the brain floats inside the skull, it moves – sometimes with great force – when the head is exposed to an impact. By applying light pressure to the sides of the neck, the Q-Collar increases blood volume in the brain's venous structures, reducing the harmful internal movement that causes brain injury.

What device helps prevent concussions? ›

The Q-Collar is a non-invasive device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from effects associated with repetitive sub-concussive head impacts.

How should people and athletes protect themselves from brain injury? ›

Avoid head-to-head, arm-to-head or foot-to-head collisions with other athletes. Wear the right protective equipment for your sport, such as helmets, padding, shin guards, and eye and mouth guards. Protective equipment should fit properly, be well maintained, and be worn consistently and correctly.

What is a Q-Collar device? ›

The non-invasive device, called Q-Collar, is a C-shaped collar that applies compressive force to the neck and increases blood volume to help reduce movement of the brain within the cranial space which may occur during head impacts.

Is diffusion tensor imaging (FDA) approved? ›

DTI can detect this (leaking water), making it the best marker for brain injury. At LifeSciences Imaging Partners, we use DTI data and FDA approved software to provide 3D color tractogram that show exactly where a brain has suffered a critical traumatic injury. DTI is an FDA-cleared Protocol.

What are the pros and cons of head collars? ›

Unlike a muzzle, head collars still allow dogs to pant, bark, drink, and eat. That said, though plenty of trainers and veterinarians recommend head collars, most dogs find them unpleasant to wear (at least initially), and they can cause injury—just like any tool can become cruel or unsafe when used incorrectly.

What is the device around NFL players' necks? ›

The NFL neck bands that you may have seen football players wearing is called a Q Collar. It's a head safety device that's produced by a company called Q30 and approved by the US Food & Drug Administration.

How much does a Q-Collar cost? ›

Called Q-Collar and costing $199, the device restricts the flow of blood from the head, and, if science touted by the company is accepted, gives the brain an extra layer of cushioning. “I can't think of anything we can do that is so simple but also so important,” Dr.

What protects the brain from concussion? ›

Concussions and Head Injuries

The skull protects the brain against penetrating trauma, but does not absorb all the impact of a violent force. The brain is cushioned inside the skull by the surrounding cerebrospinal fluid.

What technology is used to help concussions? ›

EEG is proving to be an optimal tool for real-time monitoring of brain activity in concussion rehabilitation. The use of EEG can be extremely beneficial to understanding the changes that occur in the brain after concussion and make these changes “visible” to patients and their clinicians.

What protective equipment is needed for concussions? ›

Helmets and Other Headgear. Helmets are designed to mitigate the likelihood of head injuries from an impact to the head by dissipating and distributing the energy of impact and protecting the head from penetration.

Can an athlete recover from a brain injury? ›

While most adolescent players recover from a concussion in one to three weeks, about 10 percent will have prolonged symptoms for several months, affecting many aspects of school. Persistent symptoms typically involve headaches, difficulty concentrating, poor memory and difficulty staying organized.

What are two ways to prevent brain injury? ›

Strategies for preventing TBIs caused by traffic accidents and collisions include protected bicycle lanes, helmets for cyclists, seat belt wearing for car passengers, and hands-free phone use to reduce distracted driving.

What helps protect the brain from injury? ›

Reduce your risk of a traumatic brain injury by following these tips:
  • Wear your seat belt. ...
  • Don't drive under the influence of drugs or alcohol. ...
  • Don't text or use a cell phone while driving. ...
  • Wear a helmet. ...
  • Prevent falls at home. ...
  • Prevent head injuries in children.

When was the Q-Collar FDA approved? ›

Following its review, including a request for additional information, the FDA authorized the Q-Collar for sale as an “over-the-counter” Class II medical device in February 2021. The agency declared that studies showed the device "may reduce the occurrence of specific changes" in the brain associated with brain injury.

What company owns the Q-Collar? ›

Based in Norwalk, Q30 Innovations' product, the Q-Collar, applies light pressure to one's neck, slowing down blood flow from the head leaving more blood surrounding the brain which helps limit brain movement, explained Tom Hoey, co-CEO of Q30 Innovations.

What is the name of the United States agency that regulates the safety of prescription medications? ›

Food and Drug Administration (FDA)

Which government agency oversees the regulation of prescription drugs biologics and devices marketed in the United States? ›

The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.


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