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The EarliPoint System is indicated for use in specialized developmental disabilities centers as a tool to aid clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) for patients ages 16 months through 30 months.

The EarliPoint System is a medical device for diagnosis of Autism Spectrum Disorder (ASD) in children. EarliPoint System consists of the following: - EarliPoint WebPortal to enter the patient information and for access to the patient evaluation results, - EarliPoint Device with eye-tracking capability captures the patient visual response to social information provided in the form of a series of age-appropriate videos - Artificial intelligence software analyzes the eye-tracking data and provides a diagnosis for ASD. - Eye-tracking data also outputs 3 indices (called EarliPoint Severity Indices) that proxy the ADOS-2 and Mullen validated ASD instruments - Social Disability Index correlates and proxies ADOS-2 - Verbal Ability Index correlates and proxies the age equivalent Mullen Verbal Ability score - Non-verbal Ability Index correlates and proxies the age equivalent non-verbal Mullen Ability score