Cognoa raises $11.6M to continue validation, FDA submission for child development assessment app

By Heather Mack
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Palo Alto, California-based Cognoa, which makes an app to assess child development, has raised $11.6 million in a round led by existing investor Morningside. This brings the company’s total funding to over $20 million.

By analyzing parent-provided information and videos of a child’s natural behavior, the Cognoa 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 app is intended for use in children aged 18 months to 7 years old, and while it does not provide a diagnosis, parents can take the evaluation to the pediatrician. The company has completed several clinical validation studies and has been used by 300,000 families.

“The trend of using patient-reported outcomes (PROs) and machine learning to provide diagnoses has grown exponentially in the healthcare field, and Cognoa is a leader in the area of assessments for developmental and behavioral conditions” Dr. Isaac Cheng, an investor at Morningside, said in a statement. “We believe Cognoa can significantly improve the standard of care for child behavioral development and are committed to supporting the clinical validation and FDA approval of the first machine learning-based diagnostic for early diagnosis of developmental delays.”

The latest funding will be used to for additional validation studies on the path towards FDA submission as well as to expand the app's use with pediatricians, employers and insurers.

Cognoa was founded in 2013 with the goal of making child developmental assessments available to everybody. The American Academy of Pediatrics recommends children undergo numerous screenings to identify if children are at risk for developmental conditions such as autism, but a recent CDC report shows fewer than half of children receive such assessments when concerning signs are first noticed. So, Cognoa founders developed an app at Harvard and Stanford medical schools that could offer a free, convenient way for any parent to perform the assessment themselves.

“Our goal is to improve families’ lives while supporting clinicians by enabling earlier diagnosis and improved outcomes for children,” Cognoa CEO Brent Vaughan said in a statement. “Cognoa’s next phase of growth will involve not only engaging in additional clinical validation and pursuing FDA approvals, but also working with employers and health plans to offer our clinically-validated assessment and child development support platform to employers to support [employees who are] parents.”