Abstract
Cognoa said that its artificial intelligence (AI)-based software platform for behavioral health conditions has received the FDA’s Class II diagnostic medical device designation for autism. The designation will expand its ability to offer its solution to enterprise customers, healthcare payers, and directly to clinicians in primary care settings.
In a study published by Stanford researchers February 12, 2018, in the Journal of Autism and Developmental Disorders, the electronically administered, seven-question autism spectrum disorder (ASD) screen showed 89.9% sensitivity and 79.7% specificity in detecting ASD. “In a high-risk clinical setting, the MARA [Mobile Autism Risk Assessment] shows promise as a screen to distinguish ASD from other developmental/behavioral disorders.”
Cognoa’s platform has been clinically validated to identify autism in children as early as 18 months of age. While ASD can be diagnosed as early as age two, most children are not diagnosed with ASD until after age four, according to the U.S. Centers for Disease Control and Prevention (CDC).
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