Canvas Dx supports diagnosis in a few weeks to aid children and their families in accessing early interventions. Credit: Caleb Woods on Unsplash.

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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.