FDA approves autism diagnostic tool for young children
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The FDA has granted 510(k) authorization for EarliTec Diagnostics’ second-generation autism evaluation tool for children aged 16 months to 30 months, according to a press release.
“Early diagnosis can make all the difference in helping children with autism get the support they need to develop essential language and communication, social and cognitive skills,” Sarabeth Broder-Fingert, MD, MPH, a member of EarliTec’s clinical advisory board, said in the press release from Earlitec, a digital health company. “The brains of infants and young children show remarkable neuroplasticity, forming millions of neural connections as they learn and experience new things like social interaction. By enabling clinicians to make earlier diagnoses, EarliPoint has the potential to help families take advantage of this plasticity and tailor interventions to help their children as needed to ultimately live their best and happiest lives.”
The updated EarliPoint Evaluation uses curated scenes of social interactions on a portable tablet and eye-tracking technology to measure more than 120 focal preferences per second. Using age-expected reference metrics, the evaluation tool determines if a child is missing key moments of social learning.
“Although the prevalence of autism is growing, our health care system is missing a critical developmental window for children,” EarliTec CEO Tom Ressemann said in the release. “Our goal is to help parents and care providers access earlier autism diagnosis during the life stage when interventions can be most impactful.”
Perspective
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New technologies are rapidly expanding our abilities to advance science, and EarliTec Diagnostics has developed a technique for early identification of autism. The tablet application has been well researched developmentally, following on many research studies in the field that identify concerns in toddlers 16 to 30 months. Earlier identification raises the concern about what to do next, and here researchers have not identified many effective, viable interventions for this age range of infants and toddlers. We have to be particularly concerned about inequities in service access — who will have access to this new technology and who can get potential supports — and at what cost?
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