WRITTEN BY Shannon Ashley The American Academy of Pediatrics (AAP) recommends that all children get screened for autism spectrum disorder at their 18- and 24-month well-child checkups. Today, those recommendations have been significantly enhanced. These new guidelines now recommend developmental and behavioral surveillance at 9-, 18-, and 30-month visits in addition to the standardized ASD screening at 18 and 24 months old.…
Currently, most pediatricians choose to refer children to a specialist to be diagnosed and treated for behavioral conditions such as autism — often with waitlists of a year to three years. Nationwide, we continue to face an enormous and growing shortage of specialists, so the heartbreaking reality for most children and families is delayed diagnosis and late access to treatments.…
Cognoa launches a pivotal study to demonstrate the effectiveness of its diagnostic aid for autism spectrum disorder (ASD). Read article here.
Digital therapeutics clinical trials enable collection and analysis of data in real time, but considerations like standardization of analysis, trial endpoints and placebo controls are critical, experts at the DTx East conference in Boston said. Read full article here.
Google Glass has been used for everything from opera glasses to helping workers on factory floors. More recently, it’s been used to help children diagnosed with autism spectrum disorder (ASD) to better recognize emotional cues in conversation. Now a company called Cognoa is licensing that software to bring it to more kids. Read full article here.
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.
