Earlytech Diagnostics Has announced that it has received FDA 510 (k) clearance for a device that helps physicians diagnose Autism Spectrum Disorder in children aged 16 to 30 months.
A tool called EarliPoint Evaluation uses eye-tracking technology to monitor a child’s facial behavior while they watch short videos of other children interacting with each other. The technology measures focus and responsiveness, which can be compared to age-expected metrics.
“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 Srinivasan Narayanan, Chief Technology Officer at EarliTec, in a statement. “How we measure a child’s behavior per moment does not provide an objective measure of each child’s strengths and weaknesses today – a system that is universally available and accessible to all families – it provides a digital health platform that can support care in the future.” , So that all people with autism receive timely, unique care. “
Why it matters
The company initially pitched the tool as a way to detect the symptoms of ASD, so that children can get help more quickly. ASD on CDC notes can sometimes be detected at 18 months or younger, and an experienced professional can reliably diagnose the condition in children around 2 years of age. But many people are diagnosed later, sometimes adolescents or adults, which can delay care.
However, there has been some progress with earlier diagnoses. A A recent CDC study found that 4-year-old ASD detection was four times more possible in 2016 than in 2002. Yet, there are gaps; Black and Hispanic children without intellectual disabilities were 30% less likely to be diagnosed at age 4 than white children.
“EarliTec was founded to advance ASD care by developing new approaches to diagnosing, monitoring and treating children. Understanding the clinical progression and symptoms for individuals may be the appropriate intervention to maximize profits,” CEO Tom Reesman said in a statement.
“Today’s clearance is an exciting first step, and we look forward to continuing our ongoing partnership with physicians who can use EarliPoint assessments to diagnose autism in young children and help children and families get the interventions and support that is most beneficial.”
In February, Arlitech announced that it had scored A 19.5 million in Series A funds, which it plans to use to support its 510 (k) deposit and to commercialize and expand its platform.
EarliTec is not alone in the digital autism detection space. Cognac Last summer it received FDA De Novo clearance for its ASD diagnostic aid, the Canvas Dx. It uses machine learning to analyze video of a child’s behavior as well as parental responses to questions to help physicians identify the condition in children aged 18 months to 5 years.