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First-Of-Its-Kind Autism Software Could Help Diagnose, Treat Children Faster: FDA

The US agency says a lack of specialists often lead to delays in diagnosing children and prevents them from getting much-needed help during a treatment time frame, which the new breakthrough device can help fix.

Smiling mother taking selfie with autistic son while sitting on sofa at home

The US Food and Drug Administration has authorized first-of-its-kind breakthrough medical software that could help diagnose children with autism spectrum disorder (ASD) early and get them therapy sooner. The software uses machine learning, and a combination of apps and specialists working remotely to give an initial assessment whether a child has ASD before being referred to a specialist.

Cognoa submitted a de novo application for its Canvas Dx in September 2020 and was granted marketing authorization on 2 June. The software as a medical device (SaMD) is now authorized for children between the ages of 18 months and 5 years who show potential symptoms of ASD

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