US firm Cognoa is targeting FDA approval for its AI-based smartphone app – which aims to improve the current approach to diagnosing autism in children

By Jamie Bell

A new digital method for diagnosing autism in children may be set for FDA clearance after demonstrating “unparalleled accuracy” in a real-world study.

Cognoa — a California-based paediatric behavioural health company — has developed a prescription-based smartphone app that allows parents to complete a questionnaire, and take a series of short videos of their child.

This information is analysed using AI to produce a diagnosis for autism spectrum disorder (ASD), which can then be either dismissed or confirmed by a paediatrician in the primary care setting.

Cognoa is on the verge of submitting an application to the FDA, and is hoping to gain regulatory approval for its app in the second half of 2021.

If successful, the app will become the first digital diagnostic for autism to gain FDA clearance in the US, and — according to Cognoa CEO David Happel — can help prevent parents having to wait years to find out if their child has ASD.

“Our goal is to get these kids diagnosed and started on their individualised treatment programmes, which can begin to influence their lifelong outcomes in a very positive way,” said Happel.

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