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General Questions
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 30 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 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 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 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.
Services
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.
Pricing & Payment
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 30 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.
Service Locations
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 30 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 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 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 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.
