September 11, 2017
Boston-based eye tracking company SyncThink has made major changes to its marketing materials since the FDA objected to its labeling in a warning letter. The letter is dated July 31st; MedCityNews first spotted the missive.
"Specifically, the EYE-SYNC device was cleared as a prescription device under K152915 with the following indications for use: recording, viewing, and analyzing eye movements...
June 26, 2017
SyncThink, a Boston-based applying VR and eye-tracking to assess ability to focus as an indicator of concussion damage, has launched the next generation of its FDA-cleared EYE-SYNC platform.
“Concussion is the most underreported, underdiagnosed, and underestimated type of brain trauma,” CEO Ernest Santin said in a statement. “There is no universally accepted, evidence-based definition of...
August 23, 2016
The FDA has granted de novo clearance to two concussion assessment software products from ImPACT Applications. The Pittsburgh-based company developed its original software in the 90s for computers, though the clearance also includes ImPACT Pediatric, a newer version of the tests for children that runs on an iPad.
"ImPACT's FDA clearance is a huge step forward for the industry, for athletes and...
December 1, 2015
It's hard to imagine a better blend of high tech and low tech than an iPhone stuck to the bottom of a plastic bucket. But that combination is exactly what the diagnosis of vestibular conditions in children calls for, according to physicians at Boston Children's Hospital, who recently validated the technique in a paper published in the International Journal of Pediatric Otorhinolaryngology....
August 26, 2013
The Cleveland Clinic developed the Cleveland Clinic Concussion Assessment System (C3), a two-year-old iPad app that measures concussion severity and recovery, to "bring continuity of assessment across a large healthcare organization," according to biomedical engineer Jay Alberts. It now is showing promise as a way to maximize limited resources for treating head injuries in rural communities.