Oculogica has received US Food and Drug Administration (FDA) 510(k) clearance for its SNAP concussion test, a non-invasive diagnostic tool designed to assess concussion in just 90 seconds.

The SNAP test combines eye-tracking technology with symptom severity assessment to provide clinicians with a multi-modal approach to concussion diagnosis. According to the company, the test achieves 90% sensitivity and 94% specificity, making it one of the most accurate FDA-cleared concussion assessment tools available.

Designed for use in both indoor and outdoor settings, SNAP can be administered immediately after a head injury, either on the sidelines of sporting events or in clinical environments. The system does not require a pre-injury baseline assessment, simplifying its use in emergency and routine care settings.

During the examination, patients follow a visual stimulus displayed on a screen while an eye-tracking camera records their eye movements. The captured data are then analysed using a proprietary algorithm to determine whether a concussion is present. SNAP can operate as a standalone device or as a software application on a smartphone or tablet.

The development of SNAP was supported by funding from the US Department of Defense and took approximately four years to complete. The clearance builds on Oculogica’s earlier success with the EyeBOX concussion test, which became the first FDA-cleared concussion diagnostic tool that did not require a pre-injury baseline when it received approval in 2018.

With the latest clearance, Oculogica now holds six FDA clearances related to concussion diagnosis, further expanding its portfolio of diagnostic technologies for head injuries.

 

Source: oculogica.com

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