1.5 Minute ConcussionTest “Sway” Issued CE Mark In EU as Medical Device

Sway Medical is a US medical device company who’s software turns an iPhone or iPad into a mobile medical device that provides immediate medical grade, objective concussion measurement to medical professionals

TULSA, OK, USA, 07-Sep-2016 — /EuropaWire/ — SWAY MEDICAL LLC, A UNITED STATES MEDICAL SOFTWARE COMPANY, WAS ISSUED THE EUROPEAN CE MARK TO MARKET THE SWAY SYSTEM. SWAY IS A VALIDATED IOS APP BASED CONCUSSION MANAGEMENT SYSTEM.

Sway Medical LLC (Sway) would like to announce its official availability in all European Union Countries. Sway was issued its CE Mark after being marketed in the United States and Canada for two years. This is significant because European sports organizations ranging from youth through pro level now have an affordable and convenient sideline assessment tool supporting concussion related medical decision making. 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. Licensed athletic trainers, physical therapists and athletic therapists are able to join physicians in acutely managing the underserved market of youth sports, ages six and older.

Concussion injuries are very common in sports, often going un-reported or ignored until the obvious symptoms have incapacitated the athlete or draws 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.

The Sway Balance™ System is available for purchase by licensed medical professionals involved in school, occupational or sports medicine through www.swaymedical.com. Additional protocols are available to assess an individual’s “Fall Risk” or “Functional Status”.

Sway is very excited to introduce this technology to the European Union. The product’s utilization in sports alone will reduce the unintentional misdiagnosis often made when relying on subjective testing protocols such as BESS & SCAT. Rapidly obtained objective data improves outcomes and medical decision making when assessing acute concussion injury, whether in the clinic or on the playing field. The Sway Balance™ System offers referral physicians immediate, remote access to test results once a test is performed. Baseline and event testing is performed via a free app downloaded to any Apple mobile device by a licensed user. Sway invoices an annual fee, which allows the organization to perform unlimited testing for a 12 month license period. The average annual cost per althlete is less than $4.50 USD, while a system user may be added for additional $50.00 annually.

Media contacts:

For further information, please contact sales@swaymedical.com or (612) 888-7929 or Frank Wolfe (918) 430-5650 via WhatsApp