EarliTec Diagnostics

EarliPoint Health is a healthcare technology company specializing in FDA-cleared eye-tracking diagnostic systems for early autism spectrum disorder (ASD) detection and assessment in children ages 16 months through 95 months (7–8 years). The EarliPoint System is a portable, tablet-based device that measures visual attention biomarkers through proprietary algorithms to provide objective, quantifiable data supporting qualified clinicians in ASD diagnosis and treatment progress monitoring. The system captures eye-gaze patterns while children watch video scenes featuring social interactions, analyzing three clinically aligned indices: language, cognition, and social engagement. The company's technology is grounded in decades of developmental research, with clinical validation from large-scale, double-blind studies published in the Journal of the American Medical Association (JAMA) in collaboration with Yale University and Emory University. FDA clearance was obtained via 510(k) submission, confirming substantial equivalence and safety standards. EarliPoint Health addresses critical gaps in early autism diagnosis—the average age of diagnosis in the U.S. exceeds 4 years, well past optimal intervention windows. The system is designed for clinical use in pediatric practices, behavioral health centers, child neurology clinics, and primary care facilities. Administration requires trained staff; interpretation requires qualified clinicians. Results are delivered same-day as detailed diagnostic or progress-tracking reports. The company operates an EarliPoint Network of partner clinics and research institutions including Drexel University Autism Institute, Cincinnati Children's Hospital, University of Nebraska Medical Center, and Easterseals Florida, expanding access across rural and underserved communities.