1. The FDA authorized the Q-Collar despite internal reviewers warning that pivotal studies were flawed, altered without proper approval, and failed to meet prespecified endpoints.
2. Evidence supporting the device’s purported concussion protection is scientifically unsound, relying on unverified hypotheses, surrogate MRI biomarkers, and inconsistent or duplicated data.
3. The device’s mechanism—jugular vein compression to increase intracranial blood volume—has not been shown to provide clinical benefit, and FDA documentation explicitly states it does not prevent concussion.
4. Q30-funded research faced methodological concerns, including retroactive endpoint changes and data anomalies, leading to expressions of concern for multiple related publications.
5. More than 46,000 units have been sold and adopted by adolescents and professional athletes, even though users reported no noticeable protective effect.

Source: The BMJ