Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health conditions, announced that the U.S. Food and Drug Administration (FDA) has granted the company’s De Novo classification request for its autism diagnosis aid, Canvas Dx. The AI-based device is the first FDA-authorized diagnosis aid designed to help primary care professionals diagnose autism in the primary care setting.
Canvas Dx is an artificial intelligence (AI)-based diagnosis aid designed to equip primary care primary care professionals to accurately and efficiently diagnose autism in children at risk for developmental delay. Canvas Dx evaluates both caregiver information completed at home via an app and physician inputs, and if the information is sufficient, generates a result that the physician uses as an aid to diagnose or rule out autism and direct appropriate next-steps-in-care. From the time of parental or physician initial concern to diagnosis, Canvas Dx is designed to help facilitate a diagnosis in a few weeks – not months or years, as is standard in today’s diagnostic processes – so that children and families can access early interventions and appropriate care sooner. With its AI algorithm trained using diverse datasets in terms of race, gender, educational level, and socioeconomic status, Canvas Dx has the potential to help primary care professionals avoid biases and disparities existing in the current autism diagnostic process. The FDA marketing authorization has been granted following a successful pivotal study in which the device exceeded study endpoints.
Canvas Dx is intended for use by health care professionals as an aid in the diagnosis of autism spectrum disorder (ASD) for consumers ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or health care provider organization. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only.
Cognoa is a pediatric behavioral health company developing diagnostic and therapeutic solutions with the goals of enabling equitable access to care and improving the lives and outcomes of children and families living with behavioral conditions, starting with autism. Cognoa’s products are intended to be routinely prescribed by provider organizations and covered by insurers.
This was reported by Cognoa on June 2, 2021.
Contact information: Cognoa, 2185 Park Boulevard, Palo Alto, California 94306; 650-391-9402; Website: https://cognoa.com/