Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of Autism Spectrum Disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. 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 (Rx only).
There are no contraindications to using Canvas Dx.
Canvas Dx is intended for use by healthcare professionals trained and qualified to interpret the results of a behavioral assessment examination and to diagnose ASD.
Canvas Dx is intended for use in conjunction with patient history, clinical observations, and other clinical evidence the healthcare provider determines are necessary before making clinical decisions. For instance, additional standardized testing may be sought to confirm the Device output, especially when the Device result is not Positive or Negative for ASD.
Canvas Dx is intended for patients with caregivers who have functional English capability (8th grade reading level or above) and have access to a compatible smartphone with an internet connection in the home environment.
Canvas Dx may give unreliable results if used in patients with other conditions that would have excluded them from the clinical study. Among those conditions are the following:
Canvas Dx evaluation should be completed within 60 days of the time it is prescribed because neurodevelopmental milestones change rapidly in the indicated age group.