EarliTec Diagnostics has received the US Food and Drug Administration (FDA) 510(k) approval for EarliPoint Evaluation for autism spectrum disorder (ASD) for children aged 16-30 months.
The digital health company is engaged in developing novel diagnostic and therapeutic products for children with ASD and early childhood vulnerabilities.
EarliTec leverages its dynamic quantification of social-visual engagement (DQSVE) technology for the EarliPoint Evaluation tool.
The technology captures a child’s moment-by-moment looking behaviour, which is otherwise undetectable with the human eye.
The company said that its EarliPoint Evaluation is the first objective measurement tool designed to help clinicians in the diagnosis and evaluat9ion of ASD.
According to the clinical data, the tool enabled a safe, consistent and effective ASD diagnosis, along with measurement of social disability and cognitive ability levels in children.
The FDA approval of EarliPoint Evaluation was based on positive results from two studies, a clinical trial and a repeatability and reproducibility study, in more than 500 children.
EarliTec chief technology officer Sreeni Narayanan said: “This is a significant milestone as we continue to develop innovative technologies designed to improve the lives of children and families affected by autism.
“It provides a digital health platform that can support care in the future, so that all individuals affected by autism receive timely, individualised care.”
EarliPoint Evaluation is carried out by a trained technician and involves a child watching a series of short video scenes depicting social interactions between children.
The tool directly measures a child’s preferential attention to critical social information and provides the first objective diagnostic tool for providers.
Also, its eye-tracking technology will monitor the child’s focus and responsiveness and compares the data to age-expected reference metrics using patented analysis technology.
EarliPoint is said to support the early identification of ASD and provide the EarliPoint Severity Indices that compare the social disability and verbal and non-verbal abilities.
EarliTec chief executive officer Tom Ressemann said: “Early intervention is one of the most important factors for improving lifetime outcomes, yet prolonged diagnostic journeys delay the possibility of treatment.
“EarliTec was founded to advance ASD care by developing new approaches to diagnosing, monitoring and treating children. Better understanding the clinical progression and symptoms for individuals can result in tailored interventions to achieve the greatest gains.”
