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WESTPORT, Conn., March 1, 2021 /PRNewswire/ -- Q30 Innovations is pleased to announce the FDA's recent authorization to market the Q-Collar in the United States. The FDA clearance is a major step forward in the company's mission to help better protect athletes from the effects of repeated head impacts.
The FDA's decision was based on a rigorous review of eight years of scientific research and clinical trials that demonstrate the safety and efficacy of the Q-Collar, including prospective, longitudinal studies in the United States with approximately 450 male and female athletes. The football study showed that over the course of a season of play, 77% of the collar wearing athletes had no significant changes in their deep brain tissues (white matter), compared to 73% of non-collar wearing participants who experienced significant changes. No adverse events have been associated with the use of the Q-Collar.