Canvas Dx
Cognoa
Combines caregiver questionnaires, video of the child, and clinician input into an algorithmic diagnostic aid for autism spectrum disorder in children aged 18 months to 6 years.
At A Glance
- Manufacturer
- Cognoa
- Medical specialty
- Psychiatry and Behavioral Health
- Clearance route
- De Novo
- Year authorized
- 2021
- Modality
- Multi-source behavioral data
- Role in workflow
- Diagnostic aid
The bottleneck in autism diagnosis is not diagnostic difficulty for a specialist. It is that specialist waitlists routinely run past a year, during which the intervention window that matters most is closing. A device that lets a primary care clinician reach a supported determination is attacking the waitlist, not the diagnostic accuracy.
Where It Is Used
- Autism diagnostic support in primary care
- Reducing time to diagnosis where specialist waitlists are long
- Structured assessment without a developmental specialist
Limitations Worth Knowing
The device returns positive, negative, or indeterminate, and the indeterminate rate is not small. Those children still need specialist assessment. Performance was established in a specific age band, and it is a diagnostic aid, not a diagnosis.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.