Diagnostics

FDA slaps SyncThink with warning letter over concussion detection claims

The FDA took issue with SyncThink marketing its eyetracking test as a concussion detection tool.

By Stephanie Baum on September 08, 2017 9:12 pm

The U.S. Food and Drug Administration sent a warning letter to SyncThink calling for the medtech business to stop marketing its device as a concussion detection tool since its device had not been approved for that indication from the FDA. The letter was posted on the regulator’s website this week and underscores the continued risk of medtech developers misleading consumers as competition in the concussion detection market heats up.

SyncThink’s device Eye-Sync was cleared as a prescription device for the purpose of recording, viewing, and analyzing eye movements to help identify visual tracking impairment in human subjects, according to the letter. 

“However, your firm’s promotion of the device provides evidence that the device is intended for cognitive assessment/testing of concussions and head trauma, including in injured athletes and soldiers, which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval,” the FDA wrote.

In response to the FDA’s demand that SyncThink stop misbranding its Eye-Sync device, the company said in an email that it had removed the claims from its website.

“We have removed all of the references that the FDA have identified in their letter from the SyncThink website and have reviewed the SyncThink collateral and videos to confirm that they conform to our clearance,” said Ernest Santin, SyncThink CEO.

Handheld or portable concussion detection devices have gained interest in recent years as a way of drawing attention to student and professional athletes that need to be taken out of a game and given further tests at a healthcare facility. About 7 million Americans experience a traumatic brain injury each year, with concussions the most common form of them, according to data from the Journal of the American Medical Association Pediatrics.
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BioDirection developed a portable blood test to detect proteins released into the bloodstream following a brain injury.
Oculogica developed eye-tracking technology diagnostic device called EyeBox. Two Department of Defense studies for the diagnosis of concussion are evaluating a trauma-grade version of the device, according to its website. It also has clinical trials for concussion diagnosis underway at five sites.
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