Canvas Dx

Canvas Dx is the first and only FDA-authorized Software as a Medical Device (SaMD) that aids physicians in diagnosing autism spectrum disorder (ASD) in young children. Canvas Dx harnesses clinically validated artificial intelligence (AI) technology to aid physicians in diagnosing ASD in children between the ages 18-72 months who are at risk of developmental delay. Canvas Dx incorporates 3 separate, user-friendly inputs: 1. A parent/caregiver questionnaire that asks about the child’s behavior and development collected via a parent/caregiver facing app 2. A questionnaire completed by video analysts who review two videos of the child recorded by the parents/caregivers 3. An HCP questionnaire completed by a physician who meets with the child and a parent/caregiver, collected via a healthcare provider portal The Canvas Dx algorithm evaluates all 3 inputs, generating a device output for the prescribing physician to utilize in combination with their clinical judgement. Canvas Dx is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. Canvas Dx is for prescription use only. CONTACT: Email: connect@cognoa.com Phone: 1.866.4COGNOA (1.866.426.4662) Indications for Use 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). Contraindications There are no contraindications to using Canvas Dx. Precautions, Warnings The Device is intended for use by healthcare professionals trained and qualified to interpret the results of a behavioral assessment examination and to diagnose ASD. The Device is intended for use in conjunction with patient history, clinical observations, and other clinical evidence the HCP 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. The Device 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: • Suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia • Known deafness or blindness • Known physical impairment affecting their ability to use their hands • Major dysmorphic features or prenatal exposure to teratogens such as fetal alcohol syndrome • History or diagnosis of genetic conditions (such as Rett syndrome or Fragile X) • Microcephaly • History or prior diagnosis of epilepsy or seizures • History of or suspected neglect • History of brain defect injury or insult requiring interventions such as surgery or chronic medication The Device evaluation should be completed within 60 days of the time it is prescribed because neurodevelopmental milestones change rapidly in the indicated age group.