Authorization

FDA Clears the Q-Collar for Sale to Athletes in the US

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.In announcing the clearance of the Q-Collar on Friday, February 26th, 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 said, "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." The Q-Collar's FDA submission was supported by data from more than 20 independent laboratory and clinical trials that have been performed by several leading research institutions in the US and Canada. To date, the results of 17 of the studies have been published in peer reviewed medical journals. These include a series of human clinical trials involving male hockey, football and female soccer players.The Q-Collar is a novel 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.
See also:
Leave a comment
News
  • Latest
  • Read
  • Commented
Calendar Content
«    Апрель 2021    »
ПнВтСрЧтПтСбВс
 1234
567891011
12131415161718
19202122232425
2627282930