Cognoa Seeks De Novo Clearance For AI-Powered Diagnostic App For Autism After Successful Study
FDA clearance of the ASD Diagnostic app could lead to early diagnosis, improving quality of life of children with ASD and their caregivers.
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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.
This episode of our weekly podcast covers Cognoa’s development of an app to detect autism spectrum disorder early, Novocure’s customer-focused business strategy during the pandemic, and the new $585m fund created by Longitude Capital to invest in medtech, pharma and biotech.
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.