Conexiant‘FDA Said Yes, Despite Inconclusive Evidence’

FDA authorized Q-Collar neck device for “brain protection” despite internal reviewers warning evidence was flawed and failed to show concussion prevention. More than 46,000 units sold to athletes and children as young as 13—with no proof the $199 device works.

⚖️ Professional Impact

• FDA cleared device despite internal statistical reviewer recommending rejection, setting precedent for imaging markers over clinical outcomes
• Manufacturer marketed “brain protection” claims unsupported by concussion prevention data, creating liability concerns for recommending clinicians
• Six publications now have expressions of concern for duplicated data and altered endpoints supporting the device
• Professional athletes testing device reported no protective effects, contradicting marketing claims driving adoption

🎯 Action Items

• Document that FDA authorization doesn’t equal proven efficacy when discussing device with patients
• Train staff to distinguish between regulatory clearance and evidence-based recommendations for protective equipment
• Establish protocols for evaluating devices adopted by high-profile athletes before clinical recommendation
• Monitor FDA reconsideration and professional society position statements on evidence standards

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