AI Solution Detects Autism in Toddlers

A digital healthcare startup is using an artificial intelligence (AI) platform to help aid in the detection of autism. Palo Alto, CA -based Cognoa said FDA has classified the algorithm-powered solution as a Class II diagnostic medical device. The FDA designation gives the company a path to get full clearance as a medical diagnostic for autism. “The goal actually is this summer to submit to the FDA to get full clearance under a de novo as a medical diagnostic,” Sharief Taraman, vice president of medical at Cognoa, told MD+DI. “I think we should be able to get that at the end of the year or by 2019.” Network with your colleagues in medtech at ADM Cleveland, March 7–8, 2018.   The company said the average age of autism diagnosis is 4.1 years, which falls after the critical early intervention window when therapy has its greatest impact. Cognoa's first application has been clinically validated to identify autism in children as early as 18 months of age. “Getting that diagnosis early is really important because it really does change the trajectory of what’s going to happen with the patient,” Taraman said. “What Cognoa is doing is moving this waiting game and referral game for most of the cases … to [the point of] getting the diagnosis right away and not a year later.” Here’s how Cognoa’s solution works. Parents would answer a questionnaire and submit a video sample of the child. That information then comes to the pediatrician and primary care physicia...
Source: MDDI - Category: Medical Devices Authors: Tags: Medical Device Business Digital Health Source Type: news