EarliPoint System

The EarliPoint System is a Class II medical device designed to aid in the early diagnosis of Autism Spectrum Disorder (ASD) in children aged 16 to 30 months by analyzing eye-tracking data of their looking behavior during video viewing. This system leverages observational science to provide objective diagnostic support, evidenced by its pivotal study demonstrating 71% sensitivity and 80.7% specificity for ASD.

On March 26, 2025, a determination was issued to EarliTec Diagnostics, Inc., regarding their EarliPoint System. The review found the device to be substantially equivalent for its stated indications for use, thereby permitting its marketing. The EarliPoint System is classified as a Class II device intended as an aid for pediatric autism spectrum disorder diagnosis.The EarliPoint System functions by using an eye tracker to capture a patient's looking behavior while viewing videos. This data is then analyzed by software to provide a diagnosis for Autism Spectrum Disorder (ASD) and associated developmental delay indices for children aged 16 to 30 months who are at risk. The evaluation of the system included non-clinical and clinical data, with a pivotal study demonstrating the device's safety and effectiveness in diagnosing ASD with a sensitivity of 71% and specificity of 80.7%. The device's continued marketing is subject to various general controls, including quality system regulations, labeling requirements, and adverse event reporting.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific types of looking behaviors are analyzed by the EarliPoint System, and how do these patterns correlate with an autism spectrum disorder diagnosis?; How does the system account for variability in looking behavior among neurotypical children of the same age range, and what is the potential for false positives or negatives?; What were the demographics and diagnostic criteria of the participants in the pivotal clinical study, and how might these influence the generalizability of the reported sensitivity and specificity?; Are there plans to expand the validated age range for the EarliPoint System or to evaluate its effectiveness in differentiating ASD from other developmental delays?; What post-market surveillance strategies are planned to monitor the long-term effectiveness, user experience, and potential for misdiagnosis by the EarliPoint System in real-world clinical settings?