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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
