Wednesday, July 4, 2018

Doubts, confusion surround Cognoa’s app for autism diagnosis

The status of a phone application designed to diagnose autism has created confusion among scientists — and sowed skepticism about the app’s efficacy.
According to representatives of California-based Cognoa, the app’s maker, the tool is intended to radically reconfigure the speed and ease with which autism is diagnosed. The company announced in February that the U.S. Food and Drug Administration (FDA) has established that Cognoa’s software is a Class II diagnostic medical device for autism.
It turns out, however, that the agency has not cleared the app, also called Cognoa, for diagnosing autism — nor has it recognized the app as a Class II medical device. “This product is not FDA approved or cleared,” FDA spokesperson Stephanie Caccomo told Spectrum.