FDA sends warning letter to eye-tracking startup SyncThink

By Jonah Comstock
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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 in support of identifying visual tracking impairment in human subjects," Sean Boyd, the deputy director for regulatory affairs at the FDA's Center for Devices and Radiological Health wrote in the public 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."

EYE-SYNC uses infrared cameras to track a patient’s eye movements to assess the extent of the damage immediately after an injury, or to track recovery practice with an objective measure. The company has been working on eye tracking for concussions for about 10 years but recently began to incorporate VR headsets for mobile treatments. It has a partnership with the US Army, as well as customer relationships with an ever-growing number of sports organizations.

In August, SyncThink partnered with Iowa State University to deploy its Eye-Sync technology at the school, starting with its football and wrestling programs. Later that same month the company announced a deployment at the University of Texas, where the technology will be used in the football program.

The company has already made changes to address the charges in the letter.

"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," Ernest Santin, CEO of SyncThink, said in an emailed statement.

Comparing the current website to an archived version shows that some time between May 20th and July 3rd the company redid the website, replacing a large banner that read "The 60-second, objective sideline test that uses eye tracking" with the vague but evocative tagline "The future of brain technology is in the eyes".