US FDA recently granted Cognoa’s autism diagnostic device a Breakthrough Device designation to accelerate its efforts to get the first FDA-cleared medical device for the early diagnosis of autistic spectrum disorder (ASD) to market. Read full article here.
Palo Alto, Calif.-based Cognoa Inc. received breakthrough device designations from the U.S. FDA for its digital diagnostic and digital therapeutic devices for autism. Read full article here.
FDA has granted breakthrough designations to Cognoa’s digital autism diagnostic and therapeutic devices, the company announced Wednesday. The devices are designed to enable physicians to diagnose autism spectrum disorder (ASD) earlier and improve the social skills and responsiveness of children with the condition. Read full article here.
Under the program, the FDA will provide Cognoa with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions. Read full article here.
In May, a pair of studies were published in the journals Autism Research and the Journal of the American Medical Informatics Association (JAMIA) that evaluated Cognoa’s artificial intelligence-based tool for early identification of autism in children. While both investigations suggest that the tool’s performance significantly exceeded those of other standardized screeners. Read full article here.
