Dive Brief:

• FDA has granted breakthrough designation to a SyncThink device for assessing concussion.

• The device consists of a modified virtual reality headset that uses infrared cameras to capture the movement of the wearer’s eyes, generating data to support a diagnosis.

• The agency cleared the device in 2016, and the medtech hopes to expand into new applications supported by the breakthrough designation.

Dive Insight:

When assessing people with possible concussions, physicians may ask the patient to keep looking at their finger as they move it back and forth. This procedure is designed to assess whether a patient’s eyes remain focused on the finger, showing their brain is OK, or if they exhibit the erratic movement that is a telltale sign of concussion.

The EYE-SYNC device is a high-tech take on this procedure. The patient watches a dot as it moves in a circular motion. This action is captured by cameras and the resulting data is analyzed to show how well the patient’s eye motion synchronizes with the movement of the dot.

FDA granted 510(k) clearance for EYE-SYNC in the “recording, viewing, and analyzing eye movements in support of identifying visual tracking impairment in human subjects” three years ago. SyncThink secured the clearance on the strength of software validation and verification that convinced FDA the device is substantially equivalent to Fall Prevention Technologies’ balanceback.

Since then, SyncThink has landed deals with university and professional sports teams, including the NBA’s Golden State Warriors. The device’s penetration of the sports sector reflects the need for rapid concussion assessments of players but it also has agreements with organizations including Mass General Hospital and believes its product is applicable to a range of contexts.

“With millions of concussions occurring each year the need for a rapid, mobile and, most importantly, objective metric for impairment and recovery is clear and we are thrilled that the FDA is recognizing the importance of this work,” CEO Laura Yecies said in a statement.

By establishing EYE-SYNC as one of the 100-plus devices to receive a breakthrough designation, the company has set itself up to receive additional input from FDA. The medtech plans to use the extra support to “facilitate broader applications for use” of the device.

FDA has reviewed a flux of concussion-related technologies in recent months, giving 510(k) clearance to RightEye's visual tracking impairment detection device and De Novo clearance to Oculogica's EyeBOX, which uses eye tracking to measure cranial nerve function. Earlier this month, FDA awarded breakthrough status to BioDirection's Tbit platform, which aims to confirm concussion diagnoses in less than 90 seconds using a nanotechnology-based sensor to measure protein biomarkers released from the brain into the bloodstream immediately following a head trauma.