EarliTec Diagnostics
EarliTec Diagnostics (dba EarliPoint Health) develops and sells an FDA-cleared, eye-tracking-based diagnostic system that helps clinicians objectively assess Autism Spectrum Disorder in children aged 16 to 95 months, selling exclusively to U.S. healthcare providers and autism care networks.
- Company typePrivate
- Founded2019
- HeadquartersDecatur, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What EarliTec Diagnostics does
EarliTec Diagnostics, operating as EarliPoint Health, Inc., is a Plymouth, Minnesota-based healthcare technology company founded in 2019 that develops FDA-cleared eye-tracking diagnostic tools for Autism Spectrum Disorder. Its core product, the EarliPoint System, is a portable-tablet medical device that records where and how long a child watches social and non-social video scenes. Proprietary algorithms analyze these visual-attention patterns as biometric markers, generating scores across three clinically aligned indices (language, cognition, and social engagement) to aid qualified clinicians in diagnosing and assessing ASD in children aged 16 to 95 months. The system was the first FDA-authorized objective autism assessment tool for children as young as 16 months and is validated through two large-scale, double-blind clinical studies published in JAMA, with research conducted in collaboration with Yale University and Emory University.
The company sells the EarliPoint System exclusively to healthcare providers and autism care networks through enterprise field sales, supported by a "Request A Demo" funnel and an EarliPoint Network provider directory that includes a low-cost access program. Pricing is quote-based and not publicly disclosed; customers typically enter multi-year arrangements and deploy devices in clinical settings including pediatric hospitals (e.g., Nicklaus Children's, Cincinnati Children's), autism centers (Marcus Autism Center, SARRC, Cortica), regional health systems (St. Charles Health System), and community providers (Easterseals Florida). In June 2026, EarliPoint launched Skill Illustrator, an add-on that translates assessment data into actionable developmental insights, extending the platform from initial diagnosis into treatment-progress tracking and outcome measurement.
EarliTec has raised approximately $44.5 million across three financing rounds, including a $19.5 million round in February 2022 led by Bernie Marcus and the Georgia Research Alliance, a $21.5 million round in April 2024 led by Nexus NeuroTech and Clarevia Ventures, and a $3.5 million tranche in April 2026. The company is led by President and CEO Jamie Pagliaro and Chief Clinical Officer and Co-Founder Dr. Ami Klin, Director of the Marcus Autism Center and Division Chief of Autism and Developmental Disabilities at Emory University School of Medicine. The company employs 11-50 people and operates exclusively in the United States.
EarliTec Diagnostics firmographics
Firmographics- Name
- EarliTec Diagnostics
- Legal name
- Earlitec Diagnostics dba EarliPoint Health®, Inc
- Website
- https://earlitecdx.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- EarliTec Diagnostics (dba EarliPoint Health) develops and sells an FDA-cleared, eye-tracking-based diagnostic system that helps clinicians objectively assess Autism Spectrum Disorder in children aged 16 to 95 months, selling exclusively to U.S. healthcare providers and autism care networks.
- Ownership category
- akta.pro rank
EarliTec Diagnostics industry classification
Industry- Product category
- Autism Diagnostic Medical Devices
- NAICS
- Medical and Diagnostic Laboratories (62151)
- SIC
- Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Autism Diagnostic & Educational Assessment Services (EDAKAKAA)
Keywords
Where EarliTec Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Decatur
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
EarliTec Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- EarliPoint System Device and Assessment Services: FDA-cleared medical device system for clinical use. The device is indicated as a tool to aid qualified clinicians in diagnosis and assessment of ASD. Healthcare providers (clinics, hospitals, autism centers) purchase access to the EarliPoint system for use in their practices.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Clinical use pricing for healthcare providers |
Go-to-market motion1 record
Distribution channels2 records
Marketing channels5 records
EarliTec Diagnostics product offering
Product offeringCore offering
EarliTec Diagnostics, operating as EarliPoint Health, sells the FDA-cleared EarliPoint System — a portable eye-tracking medical device that captures where and how long a child watches video scenes. Proprietary algorithms convert that gaze data into objective scores across language, cognition, and social engagement indices to aid clinicians in diagnosing and assessing Autism Spectrum Disorder in children ages 16 to 95 months. The system is sold to healthcare providers, hospitals, autism centers, and clinical networks for in-practice use, not directly to consumers.
Product overview
EarliTec Diagnostics (dba EarliPoint Health) offers the EarliPoint® System as its core product—an FDA-cleared eye-tracking diagnostic aid for Autism Spectrum Disorder. The system consists of a portable tablet device that captures eye gaze data while children watch video scenes, proprietary algorithms that analyze visual-attention patterns, and detailed reporting across three clinically aligned indices (language, cognition, social engagement). The Skill Illustrator™ module extends the platform by translating assessment data into actionable developmental insights for clinicians and families.
Differentiator
Problem solved
Functional benefit
Brands
- EarliPoint System: FDA-cleared eye-tracking technology using visual attention biomarkers for autism diagnosis, indicated for children ages 16 months through 95 months.
- EarliPoint Evaluation
- Skill Illustrator
- EarliPoint Network
Products and services
- EarliPoint System FDA-cleared medical device using portable tablet-based eye-tracking to measure how children visually engage with social and non-social video scenes, producing objective reports with scores across language, cognition, and social engagement indices to aid clinicians in diagnosing and assessing Autism Spectrum Disorder in children ages 16 to 95 months. Sold to healthcare providers, hospitals, autism centers, and clinical networks; not available for direct consumer purchase.
Quantifiable outcome
- Enables autism diagnosis as early as 16 months (vs. average U.S. diagnosis age of 4+ years)
- +2 more outcomes
Companies that use EarliTec Diagnostics
Customer profileNamed customers9 records
Segments2 records
Ideal customer profiles1 record
EarliTec Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability3 records
Feature3 records
EarliTec Diagnostics partnerships and signals
Strategic signalPartnerships
Two partnerships are on record, tiered core.
- Yale UniversitycoreAcademic research partner in the development of EarliPoint System. Research conducted in collaboration with Yale University contributed to JAMA-published clinical validation studies on eye-tracking-based measurement of social visual engagement for autism diagnosis.
- Emory UniversitycoreDr. Ami Klin serves as Division Chief of Autism and Developmental Disabilities at Emory University School of Medicine. Emory-affiliated Marcus Autism Center is a key research and clinical partner. Research collaboration contributed to FDA-cleared EarliPoint System development.
Scale indicators4 records
Recent moves5 records
Expansion highlights5 records
EarliTec Diagnostics competitors and assessment
Company assessmentDirect peers
- Cognoa: Cognoa is the most direct competitor: an AI-driven, FDA-authorized diagnostic for autism spectrum disorder (Canvas Dx) targeting young children. Both companies are pursuing the same objective, early, device/software-enabled autism diagnosis use case for pediatric populations via enterprise health channels.
- RightEye: RightEye develops eye-tracking-based clinical assessment tools for neurological and developmental conditions, sold to healthcare providers. Directly comparable as a company commercializing eye-tracking-based diagnostic and screening devices into clinical workflows analogous to EarliTec's go-to-market.
Broad incumbents
- Pearson Clinical Assessment: Pearson publishes and distributes the ADOS-2 and ADI-R — the gold-standard clinician-administered behavioral autism assessments that EarliPoint is positioned to complement and partially displace. Comparable as the incumbent benchmark that defines the existing autism diagnostic workflow EarliTec targets.
- Western Psychological Services (WPS): WPS publishes the CARS-2 (Childhood Autism Rating Scale), another widely used behavioral autism diagnostic tool in clinical practice. As a publisher and distributor of established autism assessment instruments, WPS represents the legacy assessment ecosystem EarliTec's device-based modality must penetrate.
- Tobii: Tobii is the leading global eye-tracking technology platform with applications across healthcare, research, and consumer devices. Comparable as both a potential component supplier/partner for EarliTec's hardware and a broader incumbent whose technology could be deployed into autism and developmental diagnostics.
Emerging players
- Qbtech: Qbtech develops FDA-cleared, objective digital diagnostic tools (QbTest) for ADHD using sensor-based measurement of attention and activity. Comparable business model and regulatory pathway to EarliTec — device-based, objective, FDA-cleared adjunct diagnostics for developmental conditions sold to clinicians.
- Behavior Imaging Solutions: Behavior Imaging Solutions provides video-based remote behavioral observation and assessment tools used in autism diagnosis and treatment planning. Comparable as an emerging technology-enabled autism assessment company targeting the same provider ecosystem, though with a video-based rather than eye-tracking approach.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
EarliTec Diagnostics social profiles
Digital presenceEarliTec Diagnostics compliance and trust
Trust signalCompliance1 record
EarliTec Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
EarliTec Diagnostics leadership team
Management profileNumber of profiles
Profiles3 records
EarliTec Diagnostics funding detail
Funding detailFunding overview
Funding rounds3 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
EarliTec Diagnostics M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about EarliTec Diagnostics
What does EarliTec Diagnostics do?
EarliTec Diagnostics, operating as EarliPoint Health, sells the FDA-cleared EarliPoint System — a portable eye-tracking medical device that captures where and how long a child watches video scenes. Proprietary algorithms convert that gaze data into objective scores across language, cognition, and social engagement indices to aid clinicians in diagnosing and assessing Autism Spectrum Disorder in children ages 16 to 95 months. The system is sold to healthcare providers, hospitals, autism centers, and clinical networks for in-practice use, not directly to consumers.
Is EarliTec Diagnostics a public or private company?
EarliTec Diagnostics is a private company. It is classified as venture growth investor backed and is currently operating.
When was EarliTec Diagnostics founded?
EarliTec Diagnostics was founded in 2019. It employs 11 to 50 people.
Where is EarliTec Diagnostics based?
EarliTec Diagnostics is headquartered in Decatur, United States, in the North America region.
How does EarliTec Diagnostics make money?
One revenue line is on record: earliPoint System Device and Assessment Services.
Who are EarliTec Diagnostics's main competitors?
Direct peers on record are Cognoa and RightEye. Broad incumbents are Pearson Clinical Assessment, Western Psychological Services (WPS) and Tobii. Emerging players are Qbtech and Behavior Imaging Solutions.
Does EarliTec Diagnostics have an API?
No public API is recorded for EarliTec Diagnostics.
What industry is EarliTec Diagnostics in?
EarliTec Diagnostics's product category is Autism Diagnostic Medical Devices. Its primary akta.pro industry code is EDAKAKAA, Autism Diagnostic & Educational Assessment Services. Its NAICS code is 62151 and its SIC code is 3841.