Neurotechnology company SyncThink’s eye-tracking platform has been granted U.S. Food and Drug Administration designation as a breakthrough device.
The designation, which the FDA finalized guidance around earlier this year, is meant to open a pathway to approval for novel medical products that treat or diagnose life-threatening or irreversibly debilitating diseases or conditions. For SyncThink, the designation is a recognition by the FDA that its technology has the ability to solve an important and unmet need for providing objective measurements to aid in the assessment of concussions.
SyncThink uses a proprietary eye-tracking platform called Eye-Sync to help diagnose concussions and rehabilitate people suffering from them.