FDA Clears Mobile Health Platform for Autism Diagnosis, Care

By Eric Wicklund

February 26, 2018 – Federal regulators have approved a mobile health platform designed to help doctors diagnose autism more quickly – and to help parents learn how to care for autistic children.

The U.S. Food and Drug Administration recently ruled that software developed by Cognoa is a Class 2 diagnostic medical device, enabling the four-year-old, Palo Alto-Calif.-based mHealth startup to expand marketing efforts to healthcare providers and payers.

Company officials are now seeking full FDA clearance for a digital health diagnostic platform that, they say, will help doctors diagnose autism at a younger age, enabling them to develop more effective and impactful treatment programs and reducing long-term costs.

“(T)here is a profound, unmet need for earlier and more accurate diagnoses of behavioral health conditions which we know can create life-changing results for children and their families,” Brent Vaughan, the company’s CEO, said in a press release. “Cognoa is committed to conducting additional clinical studies and working with both the FDA and clinicians to further validate both our diagnostic software as well as integrated digital therapeutics that will dramatically improve the standard of care for physicians, children and their families.”

This isn’t the first time mobile health tools have been used to help in autism treatment. Two years ago, researchers at the University of Iowa found that a telehealth platform used to connect families with specialists could help parents in learning how to care for a child with autism, cutting roughly $4,000 a year in costs for in-person treatment.

READ MORE: Using Telehealth to Care for the Caregiver

Based on research done at Stanford and Harvard, Cognoa’s digital health tool adds machine-learning capabilities to a platform that guides parents in tacking their child’s progress at home and sharing that data online with specialists.

Company officials say they’ve tested their platform in clinical trials against in-person treatment, with comparable results.

The goal is to give doctors an online platform to help them diagnose autism in children younger than the average age of 4.1 years, particularly by improving access to specialists for parents (company officials say the platform can be used to detect signs of autism in someone as young as 18 months). In addition, the platform gives parents an important resource in learning how to care for their child.

“For years, primary care physicians have been referring children with suspected behavioral and developmental conditions for more extensive evaluations for autism spectrum disorders,” Dr. Daniel Coury, a Professor of Pediatrics and Psychiatry at Nationwide Children’s Hospital and The Ohio State University and Medical Director of the Autism Speaks Autism Treatment Network, said in the press release. “This results in a logjam of children, with varying levels of severity, waiting for these assessments.”

“What’s exciting is how Cognoa will be able to empower primary care physicians to make a primary diagnosis and refer children directly for treatment, greatly reducing the time from diagnosis to meaningful interventions and leading to better outcomes,” he added.

READ MORE: Is Project ECHO the Telemedicine Model That Healthcare Is Missing?

In creating a pathway for earlier diagnosis and treatment, Cognoa also bumps up against one of the enduring criticisms of mobile health – that it adds to the nation’s overworked healthcare system by creating new treatments and more opportunities to spend money.


“Back in 2014 and 2015 we were really starting down the path of let’s just prove that we can triage these kids and find them earlier,” Vaughan told TechCrunch during a recent interview. “And a lot of people embraced that, but there was certainly some that were pretty thoughtful who said if you guys find the kids earlier and the problem in the system is that kids that are identified and referred to specialists for appointments are currently waiting between one and three years to get a diagnosis, aren’t you just going to be making the problem worse?”

“So then we had to sit down and say listen, step one is being able to show that we can just screen these kids,” he added. “But longer term we think we can really aid in getting a faster diagnosis.”

The FDA action also signals support for a platform that combines AI tools with information entered by the parents. The challenge, Vaughan said, lies in developing a digital health platform that allows parents to enter the right information – and one that gives doctors the confidence to rely on that data to make a decision.

READ MORE: Global Project to Develop mHealth Games for Clinical Treatment

Early on, Vaughan said, “we were very careful to not say, publicly, that we thought that we could diagnose these kids because we thought it would just be too controversial. And the idea of using an AI-based platform, the idea of collecting information primarily from the parent, from the caregiver and from the child, that was pretty controversial.”

Now, with FDA preliminary approval in hand, the company has gone from describing its platform as a screening tool to one that’s billed as a “pediatric behavioral health diagnostics and digital therapeutics platform.”