The Food and Drug Administration has approved the EarliPoint Evaluation for ASD to help clinicians diagnose autism. (EarliTec Diagnostics)
Federal regulators have authorized a new device intended to help doctors decide whether or not children as young as 16 months have autism.
The Food and Drug Administration said this month it has granted 510(k) approval to EarliTec Diagnostics for its EarliPoint system, a prescription device “intended to aid in the diagnosis of autism spectrum disorder.” The move will allow the tool to be marketed and used on children aged 16 to 30 months.
The device, which the company calls the EarliPoint Evaluation for ASD, uses eye-tracking technology to analyze visual behavior imperceptible to the human eye and assess focus and responsiveness while a child watches a series of short videos that social interactions between children. Data is then compared with age expectations to determine if a child is missing significant social learning.
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In addition to helping clinicians determine whether children have autism, EarliTec said the system includes the EarliPoint Severity Indices, which provide information about a child’s level of social disability, as well as verbal and nonverbal skills.
“This is an important milestone as we continue to develop innovative technologies designed to improve the lives of children and families with autism,” Sreeni Narayanan, EarliTec chief technology officer, said in a statement. “How we quantify a child’s moment-to-moment behavior not only provides objective measurements of each child’s strengths and weaknesses today – measures that could be universally available and accessible to all families – it provides a digital health platform that in the future so that all individuals with autism receive timely, individualized care.”
FDA approval comes a year after the agency granted its first authorization of a device to aid in the diagnosis of autism. That product, known as the Cognoa ASD Diagnosis Tool and branded as Canvas Dx, uses an algorithm to analyze information submitted by parents and caregivers and videos of the child to determine a “positive for ASD” or “negative for ASD.” – to answer.
The Cognoa device is approved for use in children aged 18 months to 5 years. The addition of the EarliPoint device — which the FDA has determined to be “substantially equivalent” to Cognoa’s — gives clinicians a tool they can use on younger children, as young as 16 months.
“Sometimes differences in development are so subtle that parents and pediatricians are hesitant to take action until delays become more problematic,” says Dr. Christopher J. Smith, chief science officer at the Southwest Autism Research and Resource Center in Phoenix, one of the sites where the EarliPoint device has been researched. “EarliPoint represents a breakthrough that leverages solid empirical data to facilitate earlier diagnosis of ASD. It literally gives years back to families that could be better spent on intervention rather than waiting.”
EarliPoint was developed by researchers from Children’s Healthcare of Atlanta, Emory University School of Medicine and Yale University.
The FDA based its approval of the EarliPoint device on the results of two studies, jointly involving 550 children.