The US Food and Drug Administration (FDA) has granted 510(k) authorisation for EarliTec Diagnostics’ second generation of its EarliPoint Evaluation diagnosis tool for autism spectrum disorder (ASD) in children.
EarliPoint Evaluation is indicated for usage in children aged 16-30 months.
Carried out by skilled healthcare providers, the new EarliPoint Evaluation shows selected social interaction scenes on a tablet. A technology that tracks eyes will evaluate over 120 focal preferences per second.
The data obtained is analysed against age-expected reference metrics leveraging an analysis technology to evaluate if the child is missing critical social learning moments.
On data analysis, including a detailed and tailored report with test visualisations, clinicians can have an objective, quick and precise reading of autism’s presence, degree of social disability and verbal skills and non-verbal learning levels of the child.
The technology quantifies social-visual engagement by evaluating the moment-by-moment looking behaviour of the child which is not visible to the human eye.
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EarliTec CEO Tom Ressemann said: “Although the prevalence of autism is growing, our healthcare system is missing a critical developmental window for children. In most cases, EarliPoint Evaluation can be completed in an existing appointment.
“With EarliPoint’s efficiency, we anticipate that providers can shrink waitlists and help caregivers understand more quickly if their child has ASD.”