FDA-Cleared Autism Assessment Technology
Diagnose Earlier.
Treat Sooner.
Measure Outcomes.
FDA-cleared eye-tracking technology using visual attention biomarkers for autism to support early diagnosis and measurable treatment outcomes—starting as young as 16 months.
Study Locations
Join the EarliPoint® Network
Answer a few quick questions to see if you qualify for low-cost access to EarliPoint® and opportunities to join the EarliPoint® Network. Takes ~2–3 minutes.
How It Works
Quick and Easy Administration
A trained behavior technician—or any designated trained team member—can easily administer the assessment using a portable tablet.
Eye Gaze Capture
Children watch a short video while the device unobtrusively captures eye gaze data. Behind the scenes, proprietary algorithms analyze patterns of visual attention—biometric markers of social and cognitive development.
Actionable Insights
The system generates a detailed report showing the child’s scores across three clinically aligned indices: language, cognition, and social engagement. These insights support early detection and help track progress over time.
Supporting Timely, Informed Care
Same-day results help guide discussions with families and care teams.
The EarliPoint System device is indicated for use as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 30 months who are at risk based on concerns identified by a parent, caregiver, or healthcare provider (Not for direct consumer purchase; clinician use only).
Benefits for Providers
A Smarter Way to Grow Your Practice
Transform your practice with FDA-cleared diagnostic aid that provides outcome measurements and builds stronger relationships with families.
Attract New Patients
Offer FDA-cleared diagnostics to families—removing barriers to early assessment and differentiating your practice in the community.
Track Treatment Effectiveness
Communicate Outcomes with Confidence
Earn the confidence of parents, payors, and educators with transparent, easy-to-read reports that highlight progress clearly and consistently.
Proven Science
Decades of research. Breakthrough results.
The EarliPoint® System is FDA-cleared to provide visual-attention measurements that aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder, alongside established diagnostic tools.
Our research foundation includes:
- Clinical Validation — Two large-scale, double-blind clinical studies
- Peer Review — Findings published in the Journal of the American Medical Association (JAMA)
- Academic Excellence — Research conducted in collaboration with Yale University and Emory University
DATE: September 5, 2023
Eye-Tracking-Based Measurement of Social Visual Engagement Compared with Expert Clinical Diagnosis of Autism.
DATE: September 5, 2023
Development and Replication of Objective Measurements of Social Visual Engagement to Aid in Early Diagnosis and Assessment of Autism.
Why We Do This
Beverly Johnson, MHA, MS
Abigail Ley, MD
Sondra Marshall, PhD
Clinic Director, PEDAL
In our 30,000-square-mile catchment area of Central, Eastern, and Southern Oregon, EarliPoint has been transformative in improving access to timely autism diagnosis. By placing devices in primary care clinics, we reduce travel burdens for families and can complete evaluations remotely, combining the objective EarliPoint data with developmental screenings and clinical interaction to strengthen diagnostic confidence. This approach has significantly shortened wait times, empowered providers, and given families earlier access to answers and treatment. Families who come to our clinic have expressed increased confidence and acceptance of the differential diagnosis when they see the EarliPoint results that match our neurodevelopmental testing.
