Sway Medical Receives TGA Medical Device Clearance To Market In Australia
Published by Biospace - PYRMONT, Australia, Sept. 8, 2016 /PRNewswire/
Sway Medical LLC (Sway) would like to announce its official availability in Australia. Sway was issued its TGA Approval after being marketed in the United States and Canada for two years. This is significant because Australian sports organizations ranging from youth through pro level now have an affordable, objective and mobile sideline assessment tool supporting concussion related evaluations. Medical professionals and trained coaches can obtain a concussion assessment via an Apple mobile device (iPhone or iPad) and the Sway Balance System web-portal. Acute objective measurements are obtained by performing a 1.5-minute balance and reaction time test protocol. Medical professionals will not be able to improve their concussion outcomes with objective measurement on an athlete's injury or post injury recovery. A physician may have immediate access to support other medical professionals removing geography from the equation.
Concussion injuries are very common in sports, often going unreported or ignored until the obvious symptoms have incapacitated the athlete or draw the attention of a parent or coach. Second Impact Syndrome (SIS) is a serious medical condition with published mortality rates of up to 50%. SIS occurs when an athlete returns to play while still recovering from an initial concussion injury. During this time, the brain is highly susceptible to additional injury and complications. The Sway Balance System is able to accurately assess and track the acute and chronic outcome related to an athlete's balance, motion reaction time and concussion symptoms. The Sway Balance System provides a graphical representation comparing suspicious injury event tests against a pre-injury "normative" or baseline score. The comparison of event tests against an established baseline is a common measurement for traumatic brain injury diagnosis and recovery tracking.
Sway is very excited to introduce this technology to the Australia and New Zealand medical professionals, sports teams and schools. The product's utilization will improve medical outcomes with rapidly obtained objective data to support concussion evaluations both acutely and in Return To Play assessments. The Sway Balance System offers referral physicians immediate, remote access to test results from anywhere, at any time. The average annual cost per individual is less than $4.50 USD, while a system user may be added to existing systems for $50.00 USD annually.
The Sway Balance System is available for purchase by medical professionals involved in school, occupational or sports medicine at http://www.swaymedical.com/ T (612) 888-7929 or Sway AU distributor HeadSmart Sports Concussion Programme http://headsmart.me T 07 5527 9400
Duke University Sway Test Video Link: https://youtu.be/nqdR8NTvQMk