Canvas Dx vs Autizm AI

Canvas Dx is for prescription use only. To find a prescriber go to cognoa.com or email support@cognoa.com. 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 judgment. Canvas Dx is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. CONTACT: Email: support@cognoa.com 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.

Autism spectrum disorder (ASD) is a type of neurological and developmental disorder that begins in early childhood and continues throughout a person's life. As part of this project, Dr. Fayez Tabtah collected data on 1,054 children who were less than three years old. The doctor asked their parents closed questions with yes/no answers. These questions were behavioral questions, and the number of "yes" responses was totaled and recorded in a column called Q chat 10 question. If there were more than 3 “yes” in this column, the children were classified as having positive ASD. Autism AI - Mobile application for iOS, which, using machine learning, allows you to predict the presence or absence of signs of ASD with 97% accuracy. The mobile application consists of two modules: doctor and user. The Doctor module contains tests where you can determine the presence or absence of ASD in a child under 3 years of age. The User module contains tests where you can determine the presence or absence of ASD in a child, as well as a module with Computer vision, where you need to upload a photo of the child and this module will give an answer to the presence or absence of ASD in the child. Terms of Use: This test is not a complete diagnosis. Results are for informational purposes and do not constitute a qualified medical diagnosis. You should always keep in mind that the recommendations given are of a general nature. To receive accurate recommendations, you must consult a doctor! Your data is safe. The information you provide is anonymous and will not be passed on to third parties. This mobile application was developed by the SHIFO AI team