Digital Health Technologies: Eye-Tracking Diagnostic Device for Autism Spectrum Disorder

Eye-tracking–based diagnostic aids for autism spectrum disorder (ASD) are computerized cognitive assessment devices (FDA product code QPF; 21 CFR §882.1491; Class II) intended to support qualified clinicians in the diagnosis and assessment of ASD in pediatric patients identified as at-risk by a parent, caregiver, or healthcare provider. The EarliPoint Assessment (EarliTec Diagnostics / EarliPoint Health), the currently marketed device in this class, uses an eye tracker to capture moment-by-moment gaze patterns while the child views a series of brief naturalistic social videos. A proprietary algorithm analyzes visual fixation patterns and produces a Diagnostic Index Score (consistent with autism / borderline / not consistent with autism) and three EarliPoint Severity Indices (social disability, verbal ability, and nonverbal ability) intended to proxy expert-administered ADOS-2 and Mullen/DAS-II measures. The device is indicated for use as an aid, not a stand-alone diagnostic, in children ages 16 months through 95 months (7 years).