Did SyncThink Commit a Marketing Foul?

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. 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 did grant SyncThink a breakthrough device designation in February 2019 for Eye-Sync. There seems to be some confusion, however, regarding what that actually means. 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. It does not, 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.  “I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health.
• 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.