Palo Alto, California-based Cognoa’s machine learning app for pediatric behavioral health has received categorization from the FDA as a diagnostic medical device for autism, according to an announcement from the company.

By analyzing parent-provided information and videos of a child’s natural behavior, the company’s app uses machine learning to provide an assessment of whether that child is developing at the right pace, as well as to evaluate their behavioral health. The clinically-validated app can identify autism among children as young as 18 months, according to Cognoa, and so far has been used by hundreds of thousands of families.

“Today, there 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,” Cognoa CEO Brent Vaughan said in a statement. “We are very encouraged by this FDA determination of Cognoa’s AI-based software as a medical device for diagnosis. 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."

Founded in 2013 on the back of AI technology developed at Harvard and Stanford’s respective medical schools, Cognoa looks to reassure parents that their child’s development is on track, or alert them if additional attention may be necessary. In addition to serving as a diagnostic tool, the app also gives personalized recommendations for activities or interventions that parents can do at home to support development in their child.

Outside of the benefits for families, Cognoa positions its product as a way for healthcare payers or similar companies to reduce long-term behavioral health costs. The company also notes that its app can reduce the burden on clinicians and support their diagnoses.

“For years, primary care physicians have been referring children with suspected behavioral and developmental conditions for more extensive evaluations for autism spectrum disorders. This results in a logjam of children, with varying levels of severity, waiting for these assessments,” Dr. Daniel Coury, 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 a statement from Cognoa. “Cognoa has completed several well-designed clinical trials and has engaged early with the FDA. 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.”

Last March, Cognoa raised $11.6 million in a funding round led by Boston-based Morningside, bringing the company’s total funding to more than $20 million.

At the time, Cognoa said that the money would be used for continued validation studies for regulatory submission. Speaking to TechCrunch, Vaughn said that his company will likely raise another round of investments by the end of the year.