Caroline D ?

[Bigboote]

No. It was cleared by the FDA, but not for concussion prevention. Several articles, including one in the NYT, have pointed that out. From one of the articles, "Futterman directs the reader to the FDA summary, which states that the Q-Collar was not approved to prevent concussions and there are some risks to the device. "

The FDA summary of its approval says:

1. “The Q-Collar has not been demonstrated to prevent long-term cognitive function deficits and the ultimate impact on clinical outcomes has not been evaluated.”
2. “Data do not demonstrate that the device can prevent concussion or serious brain injury.”

Thanks for clarifying. It is FDA-approved to protect the brain against "repetitive head impacts."

 

[Bigboote]

I should have said "correction" rather than clarifying.

 

[stamfordhusky]

Thanks for clarifying. It is FDA-approved to protect the brain against "repetitive head impacts."

Its use is controversial and there are serious questions whether it actually does anything at all. Its approval was based on the company's own study.

"serious doubts have emerged about the science behind the device, according to an extensive review of government documents and scientific studies by The New York Times, as well as interviews with scientists who have examined research into the Q-Collar."

Will This Device Protect Athletes’ Brains, or Only Make Them Think It Does? (Published 2022)

More and more pro and college athletes are trying on the Q-Collar as they search for something, anything, that might keep their brains safe. But does it work?

www.nytimes.com

Concerns About Q-Collar Not Approved By FDA To Prevent Concussion — Concussion Alliance

Is the Q-Collar effective at concussion prevention, and is it safe? The FDA summary states that the Q-Collar was not approved to prevent concussions and there are some risks to the device.

www.concussionalliance.org

 

[oldude]

That was ElAlfy to the left of Patterson.

That would make sense. I stand corrected.

 

[darrell]

I think Caroline should look into the Q-Collar. If you’re familiar with Audrey Warren (Georgia, Texas), she wore one for similar reasons.

“As a freshman, Warren, who had a knack for taking charges, had suffered four concussions. She had several concussion-related issues until she started wearing the Q-Collar.

“I wanted to be able to play and not risk my health,” Overshown said. “They suggested I give it a try. It’s been unbelievable. Not only being safe but going out there with confidence. I don’t have to worry about that. That’s huge playing the sport we play. Confidence is everything.””

How a New Medical Device Plans to Limit Concussions in NCAAF & NFL

Read about a new medical device, the Q-Collar, and how it plans to limit concussions in college football and the NFL.

www.actionnetwork.com

 

[BobbyJ]

I think Caroline should look into the Q-Collar. If you’re familiar with Audrey Warren (Georgia, Texas), she wore one for similar reasons.

“As a freshman, Warren, who had a knack for taking charges, had suffered four concussions. She had several concussion-related issues until she started wearing the Q-Collar.

“I wanted to be able to play and not risk my health,” Overshown said. “They suggested I give it a try. It’s been unbelievable. Not only being safe but going out there with confidence. I don’t have to worry about that. That’s huge playing the sport we play. Confidence is everything.””

How a New Medical Device Plans to Limit Concussions in NCAAF & NFL

Read about a new medical device, the Q-Collar, and how it plans to limit concussions in college football and the NFL.

www.actionnetwork.com

See post #28 above.

 

[cancontent]

The Q-Collar may be controversial, but the FDA's approval doesn't help things because it sounds like they hedged on based on how I've understood their approval. Per a recent article in advance of the World Cup:

"In 2021, the US Food and Drug Administration cleared the Q-Collar for sale as a medical device and announced that research studies on the Q-Collar "appear to indicate protection of the brain associated with device use." While there's some debate among researchers regarding the methodology used in studies supporting the efficacy of the Q-Collar, the FDA also found that "no significant adverse events were associated with device use.""

World Cup players are wearing devices around their necks to prevent brain injuries. Here's how they're supposed to work.

World Cup 2023 players, including Canadian midfielder Quinn and Costa Rican forward Rocky Rodríguez, are wearing the Q-Collar to protect their brains.

www.insider.com

So which is it? If they were skeptical, why does it get approved as a medical device? If there are studies that provide valid reasons to question the original research, when does the FDA get involved and reassess?

 

[HuskyNan]

Seeing some crazy stu in this thread.