Cognoa has initiated a pivotal study to show the effectiveness of its diagnostic aid for autism spectrum disorder (ASD).
It expects to submit the results of this multi-site, prospective, blinded, active comparator study to the US Food and Drug Administration (FDA) in 2020.
The US-based pediatric behavioural health company claimed that its digital diagnostic has the potential to become the first cleared medical device to help detect autism.
The device is expected to enable doctors in primary care to diagnose autism in children as young as 18 months. Early diagnosis will enable children to receive earlier treatment.View Full Article