Eye-tracking platform EyeSync could become the standard of care for concussion following the FDA’s granting of a “breakthrough device” designation for SincThink’s virtual reality technology. The move could facilitate broader applications and continued improvement for use on patients.
“With millions of concussions occurring each year the need for a rapid, mobile and, most importantly, objective metric for impairment and recovery is clear and we are thrilled that the FDA is recognizing the importance of this work,” said SyncThink CEO Laura Yecies.
The EyeSync platform gained initial FDA clearance in March of 2016 for recording, viewing, and analysing eye movements in support of identifying visual tracking impairment in human subjects.
Developed over 15 years of clinical research, the EyeSync platform is a modified VR headset with infrared cameras that connect wirelessly and securely to a tablet where results are viewable to the clinician within 60 seconds. Through its assessments and based on extensive peer-reviewed research, abnormal patterns can be detected that are indicative of a particular visual impairment in need of targeted treatment intervention.
SyncThink says it remains dedicated to developing technology to allow everyone from athletes to patients to objectively monitor and improve their brain health and performance. See more at http://eyeonoptics.co.nz/articles/archive/dynamic-vision-training-for-athletes/.
The FDA’s breakthrough devices programme is a voluntary programme for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
