EarliTec Diagnostics

Plymouth, MN, US All United States companies → — Founded 2019

Point-of-Care Diagnostics Specialty-Focused AI

Neurology Pediatrics Psychiatry

Mental & Behavioral Health AI Neurology AI

Series B — $41M

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Products

EarliPoint

EarliTec Diagnostics

Mental & Behavioral Health AI

EarliPoint, by EarliTec Diagnostics (now EarliPoint Health), is an FDA-cleared eye-tracking system that aids clinicians in the objective diagnosis and assessment of Autism Spectrum Disorder (ASD) in children aged 16 months to 7 years, providing rapid, data-driven insights.

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About EarliTec Diagnostics

EarliTec Diagnostics, now operating as EarliPoint Health, is a digital health company dedicated to transforming autism care through early identification and intervention. The company’s core technology, the EarliPoint™ Evaluation, utilizes patented eye-tracking methods and visual attention biomarkers to provide objective, quantifiable insights into a child’s social development. This FDA-cleared medical device aids clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children as young as 16 months, by measuring moment-by-moment looking behavior at social interactions, which is imperceptible to the human eye.

Developed by leading researchers from Children’s Healthcare of Atlanta, Emory University School of Medicine, and Yale University, EarliTec’s technology aims to address the critical need for earlier diagnosis and personalized care in ASD. The EarliPoint Evaluation provides severity indices that correlate with levels of social disability, verbal ability, and non-verbal learning, enabling clinicians to tailor interventions more effectively. The company is expanding its focus beyond diagnosis to empower providers with tools that accelerate access to treatment and measure meaningful outcomes, aiming to build a comprehensive care platform for families.

Focus Areas

Autism diagnosis Autism assessment Early intervention Eye-tracking technology Social-visual engagement biomarkers Digital health Pediatric care Early childhood vulnerabilities Objective measurement tools

Business Intelligence

Key Investors	Nexus NeuroTech Ventures, Venture Investors Health Fund, Bernie Marcus, Georgia Research Alliance
Partnerships	Netsmart, Georgia Medicaid, Children's Healthcare of Atlanta, Emory University School of Medicine, Yale University
Technology	Tablet-based eye-tracking system, Social visual-attention biomarkers, High-frequency gaze sampling (~120 Hz), Explainable machine learning, Automated clinical reporting, Digital health platform
FDA Clearances	2 cleared products (estimated)

What Physicians Need to Know

Autism Diagnosis & Assessment

EarliTec Diagnostics (now EarliPoint Health) offers the EarliPointu2122 Evaluation, an FDA-cleared objective measurement tool designed to aid clinicians in diagnosing and assessing Autism Spectrum Disorder (ASD) in children as young as 16 months to 30 months, with plans to expand to age 7. This tool provides severity indices for social disability, verbal ability, and non-verbal learning, offering a comprehensive understanding of a child's developmental profile.

Early Intervention Focus

The company's core mission is to enable earlier identification of autism to facilitate timely intervention, which is crucial for improving long-term developmental outcomes. By addressing the delays often associated with traditional autism diagnoses, EarliTec aims to provide access to critical support during the most impactful developmental windows.

Eye-Tracking Technology & Biomarkers

EarliTec's proprietary technology, Dynamic Quantification of Social-Visual Engagement (DQSVE), is central to its offering. This technology captures a child's moment-by-moment looking behavior at a rate of 120 times per second, which is imperceptible to the human eye. It analyzes social-visual engagement biomarkers by comparing a child's visual attention patterns to those of typically developing peers.

Digital Health & Objective Measurement

As a digital health company, EarliTec provides a tablet-based eye-tracking assessment system that delivers objective, repeatable metrics for diagnostic assessment and outcome tracking. The EarliPoint Evaluation is FDA-authorized, representing a significant advancement in objective diagnostic tools for ASD.

Pediatric Care & Vulnerabilities

The EarliPoint Evaluation is specifically designed for young children, targeting ages 16 to 30 months, a critical period for early childhood development. The company aims to make earlier identification and treatment for autism and related early childhood vulnerabilities more accessible, addressing disparities in care and the public health challenge of delayed diagnosis.

Physician Tip

For physicians, EarliTec Diagnostics (EarliPoint Health) offers a revolutionary approach to autism diagnosis. The EarliPointu2122 Evaluation provides an objective, accurate, and rapid assessment (12-15 minutes) for children as young as 16 months, significantly reducing the diagnostic timeline from months to a single session. This allows for earlier initiation of critical interventions, which are proven to lead to better long-term outcomes. The detailed reports generated by the system offer actionable insights into a child's social disability, verbal ability, and non-verbal learning, enabling personalized treatment planning. The tablet-based, child-friendly assessment can be easily integrated into existing clinical workflows, helping to streamline the diagnostic process and potentially reduce waitlists. Furthermore, the company's commitment to expanding its use case to include treatment monitoring and population-based screening suggests a future comprehensive care platform.

EarliTec Diagnostics, now operating as EarliPoint Health, is actively building the 'EarliPoint Network' to foster partnerships with providers. This initiative aims to embed the EarliPoint Evaluation into clinical workflows, serving as a 'front door' for attracting new patients and expediting access to treatment. The company also provides clinician education and support through webinars and on-demand content. Notably, Georgia Medicaid has already included EarliPoint in its medical coverage, indicating a pathway for broader payer engagement and accessibility.

At a glance

Founded 2019

HQ Plymouth, MN, US · United States

Team size 36

CEO Jamie Pagliaro

Funding Series B — $41M

FDA clearances 2 (estimated)

Products 1

Products by EarliTec Diagnostics

1 product in the directory

EarliPoint

EarliTec Diagnostics

Mental & Behavioral Health AI

Contact vendor

What the Web Says

EarliTec Diagnostics is a health tech company focused on accelerating early autism diagnosis through its FDA-authorized EarliPointu2122 Evaluation technology. The device uses eye-tracking to analyze a child's viewing behavior while they watch short videos of social interactions, providing objective, data-driven insights into social development in children as young as 16 months. This technology aims to address the bottleneck in traditional autism identification methods, which are often slow, difficult to access, and can be biased. The EarliPoint device has shown strong diagnostic accuracy in clinical trials and has received positive attention from healthcare IT reviewers for its potential to improve early intervention and outcomes for children with autism.

Overall: Positive

Strengths

FDA-authorized for early autism diagnosis in children aged 16-95 months.
Utilizes objective eye-tracking technology to measure social visual engagement.
Aids in earlier diagnosis, which is crucial for improving long-term outcomes.
Reduces diagnosis time and costs compared to traditional methods.
Requires little training to administer, potentially increasing access to diagnosis.
Provides objective measures of social disability, verbal ability, and non-verbal learning.

Limitations

No specific negative product or employer reviews were found on G2, Glassdoor, Capterra, or Reddit.
General challenges in the healthcare IT sector can include integration with existing systems and regulatory compliance.
Some Reddit discussions mention the general stress and difficulty parents face during the autism diagnosis process, though not specifically critical of EarliTec's product.
Employer reviews for similarly named but unrelated companies (e.g., Elite Diagnostics, Tribal Diagnostics) mention issues with workload, management, and lack of advancement, but these are not for EarliTec Diagnostics.

Based on reviews from: TIME, Medical Device and Diagnostic Industry, BioSpace, Clinical Trials Arena, accessdata.fda.gov, BioWorld, YouTube, Reddit

Last updated: 2026-07-18

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Press & Coverage

BioSpace

EarliTec Diagnostics Receives FDA 510(k) Authorization for Next-Generation EarliPoint Evaluation for Autism Spectrum Disorder

EarliTec Diagnostics received FDA 510(k) authorization for the second generation of its EarliPointu2122 Evaluation for ASD for children ages 16-30 months old, and also announced its commercial launch. The technology quantifies Social-Visual Engagement by measuring a child's moment-by-moment looking behavior, aiding in early identification and providing severity indices.

2023-07

Business Wire

EarliTec Diagnostics, Inc. Raises $21.5 Million in Series B Financing; Funds to Accelerate Commercialization of EarliPoint Evaluation and Further Product Development

EarliTec Diagnostics announced a $21.5 million Series B financing round, led by Nexus NeuroTech Ventures and Venture Investors Health Fund. The funds will be used to expand commercialization efforts and advance clinical research for the EarliPointu2122 Evaluation, an autism diagnostic and assessment tool for children aged 16-to-30 months.

2024-04

GRA Venture Fund

EarliTec Diagnostics Announces $19.5 Million Financing to Advance Autism Diagnosis and Treatment in Children as Young as 16 Months of Age

EarliTec Diagnostics secured $19.5 million in Series A financing, led by Bernie Marcus with participation from the Georgia Research Alliance. This funding will support FDA 510(k) clearance, commercialization, and expansion of their digital biomarkers for early ASD identification and treatment.

2021-XX

Newsfile Corp. (via GetFeatured)

EarliTec Diagnostics Rebrands as EarliPoint Health, Signaling New Vision for Autism Care

EarliTec Diagnostics rebranded as EarliPoint Health, expanding its mission beyond diagnosis to empower providers with tools for accelerating access to treatment and measuring meaningful outcomes for autism care. The company's FDA-cleared eye-tracking technology aims to reduce the time from concern to diagnosis.

2025-10

SARRC (Southwest Autism Research & Resource Center)

First Tool to Diagnose Autism in Children as Young As 16 Months Receives FDA Clearance

EarliTec Diagnostics received FDA clearance for the EarliPoint Evaluation, an objective measurement tool to assist clinicians in diagnosing and assessing autism spectrum disorder (ASD) in children ages 16-30 months. This technology tracks eye movements as children watch videos, comparing data to age-expected metrics.

2022-06

EarliPoint Health

JAMA Publishes Two Large Studies Demonstrating the Diagnostic Accuracy of EarliTec's Evaluation for Autism in Children as Young as 16 Months

The Journal of the American Medical Association (JAMA) published positive results from a Phase III trial demonstrating that EarliTec's EarliPointu2122 Evaluation can effectively and accurately aid in diagnosing and assessing autism in children as young as 16 to 95 months old. The studies showed that moment-by-moment looking behavior is a robust biomarker for autism.

2023-09

Medical Device and Diagnostic Industry

A Better AI Tool for Diagnosing & Assessing Autism

EarliTec Diagnostics' EarliPoint Evaluation, an FDA-authorized device, helps clinicians diagnose and assess autism in toddlers using eye-tracking technology and digital biomarkers. The company recently raised $21.5 million in Series B financing to further its development and commercialization efforts.

2024-04

Netsmart

EarliPointu2122 Health and Netsmart Partner to Expand Reach of Groundbreaking Autism Assessment Technology

EarliPoint Health (formerly EarliTec Diagnostics) partnered with Netsmart to expand the reach of its FDA-cleared eye-tracking technology for autism assessment and diagnosis. This collaboration aims to help more providers access advanced tools for earlier evaluation and intervention for children.

2026-04

Frequently Asked Questions

What is EarliTec Diagnostics and how does its technology aid in autism diagnosis?

EarliTec Diagnostics, recently rebranded as EarliPoint Health, is a digital health company that has developed the EarliPoint Evaluation, an FDA-cleared objective measurement tool to assist clinicians in diagnosing and assessing autism spectrum disorder (ASD). This tablet-based system uses eye-tracking technology to capture a child's moment-by-moment visual attention to social stimuli in videos, identifying social-visual engagement biomarkers that are imperceptible to the human eye. The technology is currently authorized for children aged 16 to 30 months, with ongoing studies to expand its use to children up to seven years old.

How does EarliTec's solution integrate into existing pediatric care pathways and support early intervention?

EarliTec's EarliPoint Evaluation is designed to integrate into clinical workflows as an aid for qualified clinicians, providing objective data to support diagnosis and assessment. By offering a faster and more efficient diagnostic process, it aims to reduce lengthy waitlists and enable earlier initiation of personalized interventions, which is crucial for improving long-term outcomes for children with ASD. The company also offers a provider network access program and clinician education to facilitate adoption and effective use.

What are the key benefits of using EarliTec's eye-tracking technology for early childhood vulnerabilities, particularly in autism assessment?

The primary benefit is providing objective, quantifiable measurements of social-visual engagement, which helps clinicians understand a child's strengths and vulnerabilities in social disability, verbal ability, and non-verbal learning. This data-driven approach supports earlier and more accurate diagnoses, allowing for timely, tailored interventions during critical periods of brain development. The technology aims to enhance equity in autism diagnosis by offering an accessible and standardized assessment tool.

Can you provide details on the compliance, regulatory status, and data security of EarliTec's diagnostic tools?

EarliTec's EarliPoint Evaluation has received multiple FDA 510(k) clearances, including for its second-generation device, as a Class II medical device intended to aid in ASD diagnosis and assessment. The device complies with IEC 60601-1 for mechanical/electrical safety and IEC 60601-1-2 for EMC, with successful software verification and validation testing per IEC 62304. Patient information and eye-tracking data are securely stored and analyzed via a WebPortal, adhering to regulatory requirements for medical devices.

What is the typical pricing model for EarliTec's products, and what kind of support and training does the company offer?

While specific pricing models are not publicly detailed, EarliTec's FDA clearance is pivotal for broader market opportunities, including reimbursement and potential partnerships, with Georgia Medicaid already incorporating EarliPoint into its medical policy. The company supports clinicians with webinars, on-demand education, and a provider network access program to qualify clinical sites and connect families with evaluation locations. This comprehensive support aims to ensure effective implementation and utilization of the EarliPoint system.

What partnerships does EarliTec have, and what is the company's long-term stability and vision?

EarliTec Diagnostics (now EarliPoint Health) was developed by leading researchers at Children's Healthcare of Atlanta, Emory University School of Medicine, and Yale University, with pivotal clinical trials conducted at multiple sites including SARRC and UNMC's Munroe-Meyer Institute. The company has secured significant funding, including a $19.5 million Series A and a $21.5 million Series B round, demonstrating investor confidence. Its long-term vision, under the new EarliPoint Health brand, is to expand beyond diagnosis to empower providers with tools for accelerating access to treatment and measuring meaningful outcomes, aiming to diagnose earlier, treat sooner, and measure outcomes.

How does EarliTec address concerns about the objectivity and reliability of its measurement tools compared to traditional diagnostic methods?

EarliTec addresses these concerns through its use of objective, biomarker-based eye-tracking technology, which quantifies social-visual engagement by measuring a child's moment-by-moment looking behavior at 120 times per second. Clinical validation studies, published in The Journal of the American Medical Association (JAMA), have demonstrated high sensitivity and specificity in matching expert clinical diagnoses and accurately predicting levels of social disability, verbal ability, and non-verbal learning. This empirical data provides a reliable and consistent assessment, complementing traditional diagnostic methods.

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