EarliTec Diagnostics

The company’s flagship product, the EarliPoint Evaluation, has received FDA clearance as an objective measurement tool to assist clinicians in diagnosing and assessing autism in children as young as 16 months. Clinical data show it safely and effectively delivers diagnoses and measures levels of social disability and cognitive ability. The technology quantifies social visual engagement by tracking a child’s looking behavior while watching videos of social interactions on a tablet; this data correlates with gold-standard clinical assessments. As of April 2024, the device was deployed at multiple centers across several US states. No therapeutic products or interventional clinical trials are reported; focus remains on diagnosis/assessment. No published head-to-head pivotal trial results found; FDA clearance based on safety/effectiveness for intended use. Pipeline_breadth may expand if additional products are developed beyond current offering.