The US Food and Drug Administration (FDA) has granted de novo clearance to market Cognoa’s artificial intelligence (AI)-based autism diagnosis aid, Canvas Dx.

Canvas Dx is indicated for use by healthcare specialists to help diagnose autism spectrum disorder for patients, aged 18 months to 72 months, at risk of developmental delay based on concerns of a parent, caregiver or healthcare provider.

Canvas Dx is the first aid for diagnosing autism in the primary care setting to obtain FDA authorisation, noted Cognoa, a paediatric behavioural health company.

The device assesses caregiver data, which is gathered at home through an app, along with a doctor’s inputs. It delivers a result that can be used by the doctor as an aid to diagnose or rule out autism and recommend further necessary steps in care.

Compared to traditional diagnostic methods that can take months or years, Canvas Dx allows diagnosis in a few weeks, aiding children and their families in seeking out early interventions and proper care.

The new device’s AI algorithm is trained with varied data on race, gender, educational level and socioeconomic status. The aim is to prevent biases and disparities in the diagnostic process.

Cognoa CEO Dave Happel said: “The current system is already at a breaking point as it is unable to provide early diagnoses and intervention opportunities to many children and families.

“The FDA authorisation of our diagnosis aid, Canvas Dx, is a significant milestone in Cognoa’s development and a crucial step towards making early diagnoses more accessible to children and families – regardless of gender, ethnicity, race, zip code or socioeconomic background.”

The latest FDA authorisation is based on satisfactory results in a pivotal study, which showed that the device exceeded all pre-specified study goals.