A recent MD+DI story raised concern among readers regarding the marketing claims made by SyncThink for its Eye-Sync technology.
Editor's Note: To address any reader confusion, we have revised the headline of this article (and that of the earlier article, now entitled Premier Lacrosse League Adopts Eye-Sync as Part of Concussion Management Protocol) and have supplemented the text below concerning the FDA breakthrough device designation and the relevance of FDA's direct-to-consumer warnings. We have posted the reader comments we received after publishing the first story in the comments section of that story.
A story MD+DI published this week about the Premier Lacrosse League (PLL) adopting SyncThink's eye-tracking system into its concussion management protocol drew criticism from several readers (some of whom may be competitors). We take all reader feedback seriously and pride ourselves on accuracy in reporting so we took a closer look at the issue and reached out to the company for comment. Here is what we learned:
- FDA cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment.
- SyncThink's marketing practices landed the company in hot water in 2017. According to this FDA warning letter to the company, SyncThink was promoting the Eye-Sync device for cognitive assessment/testing of concussions and head trauma, including in injured athletes and soldiers, which FDA said would constitute a major change or modification to the device's intended use.
- As previously reported, FDA granted SyncThink a breakthrough device designation in February 2019 for Eye-Sync. As a point of clarification for our readers, FDA's breakthrough device designation program allows companies to have more frequent and less formal interactions with senior FDA reviewers. The program is intended to expedite the development and review process of a particular device. It does not in and of itself, however, mean the device is approved or cleared for the desired indication.
- FDA warned the public in April 2019 not to use devices or apps marketed to consumers that claim to help assess, diagnose, or manage head injuries. However, in describing the role of Eye-Sync in at least one athletic program, Doug Appleton, SVP Business Development at SyncThink, has stated in a press release that The Premier Lacrosse League (PLL) is “backing up their ‘We the Players’ motto by bringing cutting-edge technology like Eye-Sync to their sidelines to help their medical staff assess and manage potential concussions and most importantly, ensure their players safe return to the field.” In a follow up statement to MD+DI, a spokesperson for SyncThink said that the Eye-Sync platform “must be used with a clinician. We do not market to consumers for purchase and we don’t claim to assess concussions.”
- FDA has dedicated a page on its website to devices that are legally marketed for the assessment of head injury. SyncThink's device is not on that list.
"We appreciate your concern based on reader feedback," SyncThink said in a statement provided to MD+DI on Thursday. "The Eye-Sync platform that’s being implemented with the PLL clinicians as a part of the PLL’s concussion management protocol is FDA cleared for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairments, and received breakthrough device designation recognizing that the technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion. We’ve presented our technology accurately in the press release in that the league clinicians will use Eye-Sync with a clinician to evaluate baselines and in-game assessments."
Here are a few devices MD+DI has previously covered that have received FDA clearance or approval for a concussion or traumatic brain injury:
Banyan Biomarkers' blood-based Banyan Brain Trauma Indicator test.
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices from Pittsburgh, PA-based ImPACT Applications. The ImPACT devices are computerized tools used to test a person's cognitive function after a possible concussion.
Oculogica's EyeBox concussion test, designed to remove some of the guesswork from concussion assessment. This test does not rely on a baseline measurement for comparison.