The Food and Drug Administration (FDA) has granted 510(k) clearance to EarliPoint™ Evaluation to assist clinicians with the diagnosis and assessment of autism spectrum disorder (ASD) in children 16 to 30 months of age.
The EarliPoint Evaluation device utilizes eye-tracking technology to capture moment-by-moment looking behavior using a series of short video scenes displaying social interactions between children. The data are then compared to age-expected reference metrics to determine if the child is missing critical social information.
The clearance was based on positive results from a pivotal clinical trial (ClinicalTrials.gov Identifier: NCT03469986) and a repeatability and reproducibility study (ClinicalTrials.gov Identifier: NCT04860986), which included more than 500 individuals. Additionally, over 1000 children participated in a feasibility trial. The technology was developed by researchers at Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University.
“This is a significant milestone as we continue to develop innovative technologies designed to improve the lives of children and families affected by autism,” said Sreeni Narayanan, Chief Technology Officer of EarliTec. “How we quantify moment-by-moment behavior of a child not only provides objective measures of each child’s strengths and weaknesses today, measures that can be universally available and accessible to all families, it provides a digital health platform that can support care in the future, so that all individuals affected by autism receive timely, individualized care.”
EarliTec Diagnostics receives FDA 510(k) clearance for the EarliPoint Evaluation for autism spectrum disorder. News release. EarliTec Diagnostics, Inc. Accessed June 10, 2022. https://www.businesswire.com/news/home/20220610005563/en/EarliTec-Diagnostics-Receives-FDA-510-k-Clearance-for-the-EarliPoint-Evaluation-for-Autism-Spectrum-Disorder