FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

FDA Warns Monitor Manufacturer Over Unapproved Use

Sept. 13, 2017
A A

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.

View today's stories