The FDA told a Boston eye-movement monitor manufacturer to stop marketing the device as a tool for assessing concussions and other head injuries.
SyncThink, maker of the Eye-Sync device, did not apply for the required premarket approval or investigational device exemption for the Eye-Sync for the head-trauma assessments, which represent a new use for device, the FDA said in a warning letter.
The Eye-Sync has been cleared by the FDA as a prescription device for recording and analyzing eye movements to identify visual impairment. On its web site, SyncThink is promoting Eye-Sync for on-the-spot evaluation of potential concussions, particularly among football players; that amounts to “a major change or modification to its intended use,” the letter said.
The company web site lists Texas, Iowa State and Stanford as universities that have adopted the “revolutionary” Eye-Sync for concussion assessment in their athletic programs. The device has been written about in the mainstream media as cutting-edge technology for assessments of sports head injuries.
The device resembles a set of virtual-reality goggles, which are connected wirelessly to a suitcase-sized, portable input processing unit.