- Utilizes AI and eye-tracking to analyze children’s responses to videos, aiding Autism Spectrum Disorder diagnosis.
- It features an operator module for session management and a web portal for data handling.
- Proven safe and effective in a large-scale study, aligning with expert clinician diagnoses.
The EarliPoint System is a specialized diagnostic tool designed for use in developmental disabilities centers to assist clinicians in diagnosing and assessing Autism Spectrum Disorder (ASD) in children aged 16 to 30 months. EarliPoint system is developed by EarliTec Diagnostics, Inc.
This system employs a software algorithm to objectively analyze a child’s response to external stimuli presented in videos. The system’s core functionality involves an eye-tracking module that captures the child’s visual responses during the video sessions. The data collected is then analyzed remotely by the system’s software, which assesses ASD symptoms and provides a diagnosis.
The EarliPoint System comprises an operator module that manages sessions and a web portal that securely stores data and allows for result retrieval. The software of the system, which is powered by artificial intelligence, not only diagnoses Autism Spectrum Disorder (ASD) but also generates three EarliPoint Severity Indices that are correlated to validated ASD instruments such as ADOS-2 and Mullen scales.
A study was conducted across six U.S. sites to evaluate the clinical efficacy of the EarliPoint System. This study involved 500 patients, out of which 475 patients were analyzed. The double-blind and multi-center study compared the diagnoses made by the EarliPoint System with those made by expert clinicians. The expert clinicians served as a reference standard. The study’s results showed that the EarliPoint System is safe and effective in diagnosing ASD. No serious adverse events were reported related to its use.
Ref: “EarliPoint EarliTec Diagnostics, Inc 510(k) Premarket Notification.” n.d. Accessed January 3, 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230337
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