EarliPoint
Overview
EarliTec Diagnostics, now operating as EarliPoint Health, is a health technology company transforming the standard of care for autism. The company develops the EarliPoint System, an FDA-cleared medical device that utilizes innovative eye-tracking technology and visual attention biomarkers to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children ages 16 months through 95 months (7 years). The system measures a child’s moment-by-moment looking behavior while viewing short video scenes of social interactions, providing objective, quantifiable data that complements a clinician’s observation and judgment. This technology aims to enable earlier understanding, more informed intervention, and measurable outcomes to improve lifelong trajectories for children with autism. The system generates same-day results and provides EarliPoint Severity Indices related to social disability, verbal ability, and nonverbal ability.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- FDA-cleared eye-tracking technology
- Aids in diagnosis and assessment of Autism Spectrum Disorder (ASD)
- Objective measurement tool for social-visual engagement
- Targets children ages 16 months through 95 months (7 years)
- Captures moment-by-moment looking behavior (DQSVE)
- Analyzes visual attention data using proprietary algorithms
- Provides EarliPoint Severity Indices (social disability, verbal, nonverbal ability)
- Delivers same-day results
- Non-invasive assessment
- Complements clinician judgment with quantifiable insights
Use Cases
- Aid qualified clinicians in ASD diagnosis
- Assess ASD in at-risk children
- Track treatment progress with objective metrics
- Support early intervention planning
- Provide objective data to complement clinical observation
- Expand access to early diagnostic and assessment tools
What Physicians Need to Know
EarliPoint serves as a valuable diagnostic aid, offering objective, biomarker-based data to complement traditional clinical evaluations for ASD in young children. It can significantly reduce the time to diagnosis, enabling earlier intervention during critical developmental windows. Physicians should integrate EarliPoint results with their comprehensive clinical judgment and patient history, as the tool is not intended to replace the clinician's role in making a final diagnosis and treatment plan. The detailed reports can also be powerful in communicating findings to families and guiding personalized treatment strategies.
EarliPoint is designed for seamless integration into existing clinical workflows. The assessment is a single-session evaluation, typically taking about 12-15 minutes of video viewing time, and can be administered by a trained team member using a portable tablet. Results are generated quickly, often on the same day or within 72 hours, facilitating timely discussions with families and care teams. The system's objective data complements gold-standard diagnostic tools and can be used to track progress over time, supporting data-driven adjustments to intervention strategies.
Details
| Category | Mental & Behavioral Health AI, Neurology AI |
| Pricing |
Contact vendor
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| Deployment | Dedicated hardware (eye-tracking module and operator module, potentially tablet-based) with a web portal for data analysis and results retrieval. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
Yes AI-estimated The EarliPoint System is an FDA-cleared Class II medical device (Product Code QPF, Regulation Number 21 CFR 882.1491). It received initial 510(k) clearance (K213882) in June 2022 for children aged 16-30 months, a second-generation device clearance (K230337) in June 2023, and an expanded age indication clearance (K243891) in March 2025/2026, extending its use to children ages 16 months through 95 months (7 years). It is indicated as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD). |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurology, Pediatrics, Psychiatry |
What the Web Says
EarliPoint is an FDA-cleared eye-tracking system designed to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children aged 16 months to 7 years. It works by having children watch short videos of social interactions while a specialized camera tracks their eye movements, capturing 120 data points per second. These data are then analyzed by algorithms to identify patterns associated with ASD, providing objective measurements to support clinical diagnoses. The technology aims to facilitate earlier diagnosis and intervention, which experts believe can lead to better outcomes for children with autism.
Overall: PositiveStrengths
- Provides objective, quantitative data to aid in ASD diagnosis.
- FDA-cleared for use in children aged 16 months to 7 years.
- Can facilitate earlier diagnosis and intervention, potentially leading to better outcomes.
- The assessment is non-invasive and typically takes about 15 minutes.
- Validated in large-scale clinical studies and published in JAMA.
- Reduces waiting times for specialist appointments.
Limitations
- Requires dedicated hardware, controlled lighting, and trained staff.
- Does not provide a diagnosis on its own; it's a tool to aid clinicians.
- Some technical challenges remain, such as calibration and motion artifacts.
- Currently only available in select specialty centers and states.
- One Reddit user mentioned that the company Earli Inc. (which developed EarliPoint) had layoffs and a limited cash runway, and that the founder was a micromanager.
- The company Earli Inc. is also involved in cancer detection, which might lead to confusion with the EarliPoint autism diagnostic tool.
Based on reviews from: PMC, The Transmitter, TIME, EarliPoint Health, Els for Autism, Reddit, BioSpace, ClinicalTrials.gov, YouTube, First Choice Neurology, Compleat Kidz, Erica Tober ABA Consulting, G2, Capterra
Last updated: 2026-07-18
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