SyncThink Receives Second FDA 510(k) Clearance for Eye-Sync Concussion Test

Palo Alto, Calif.-based SyncThink has received a further 510(k) clearance from the FDA for its Eye-Sync technology as an aid in diagnosing concussion or mild traumatic brain injury.

The eye-motion tracking system uses artificial intelligence to identify concussions without the need for a baseline test. A recent study showed that Eye-Sync had 82 percent accuracy in correctly identifying patients with the conditions and 93 percent success in accurately detecting patients without the conditions, the company said.

The virtual reality-based diagnostic device received a breakthrough designation from the FDA in 2019, following initial 510(k) clearance of the technology platform in 2017.