News Report | April 2, 2018
FDA Determines Cognoa Mobile Health Platform For Autism Diagnosis & Care Is A Class II Medical Device
On February 21, 2018, Cognoa announced that the U.S. Food and Drug Administration (FDA) determined that Cognoa’s software for autism diagnosis and treatment is a Class II diagnostic medical device. The “device” is a software application/platform for a smartphone; the app consists of an artificial intelligence-based platform for pediatric behavioral health diagnostics and digital therapeutics. The FDA decision will allow Cognoa to apply for full FDA marketing clearance for the app. Cognoa’s Chief Executive Officer Brent Vaughan said the company hopes to gain full FDA clearance during 2018. Cognoa intends to offer its solution to . . .