Objective Intelligence for Autism Care

EarliPoint Health is a healthcare technology company transforming access to autism care through research-based clinical innovation. Founded on decades of scientific discovery, the company develops tools that empower clinicians with objective insights into a child’s development—enabling earlier understanding, more informed intervention, and measurable outcomes that may improve lifelong trajectories.

The EarliPoint System is an FDA-cleared medical device indicated for use as a tool to aid qualified clinicians in the diagnosis and assessment of Autism Spectrum Disorder (ASD) in children 16 to 95 months old who are at risk based on concerns shared by a parent, caregiver, or healthcare provider.

Using advanced eye-tracking technology, the system measures how a child visually engages with social and non-social scenes. These data provide objective, quantifiable information that complements a clinician’s observation and judgment during the diagnostic process.

During an evaluation, a child watches video scenes featuring social interactions. Eye-tracking sensors record where and how long the child looks at different parts of each scene. The resulting visual-attention data are analyzed by algorithms developed through years of developmental research, providing objective measures that help clinicians assess patterns associated with ASD.

The EarliPoint System is FDA-cleared. FDA clearance means the device has successfully demonstrated substantial equivalence to a legally marketed device in terms of safety and effectiveness under a 510(k) submission. This clearance confirms that the EarliPoint System meets the FDA’s rigorous standards for use as a medical device to aid clinicians in the diagnosis and assessment of ASD.

The EarliPoint System is designed for clinical use only and is not available for direct consumer purchase. Data collection can be completed by anyone trained to use the system, such as clinical staff or technicians. However, interpretation of results must be performed by qualified clinicians trained to diagnose ASD according to state guidelines.

The system is indicated for children 16 to 95 months old who are at risk for ASD based on concerns raised by a parent, caregiver, or healthcare provider.

No. The EarliPoint System does not make a diagnosis on its own. It serves as a tool to aid qualified clinicians by providing objective data that support their diagnostic assessments. The final diagnosis and care decisions remain with the clinician.

Early evaluation creates opportunities for timely support. Research shows that when developmental differences are identified before age three, children are more likely to benefit from intervention during a period of heightened brain plasticity—when learning, language, and social skills are rapidly developing.

Autism affects roughly 1 in 31 children. Yet, the average age of diagnosis in the U.S. is over 4 years old, well past the optimal window for early intervention. Long waitlists, subjective tools, and limited access to qualified providers delay evaluation—especially for rural and underserved families.

EarliPoint Health’s work addresses these challenges by offering objective, standardized tools that help clinicians identify developmental differences sooner and with greater consistency.

Traditional diagnostic tools rely heavily on observation and parent reporting, which can be subjective and time-intensive. EarliPoint Health introduces objective, technology-based measures that complement clinical judgment—helping clinicians reach insights faster and more consistently while maintaining diagnostic rigor.