Canvas Dx is a prescription diagnostic aid to healthcare professionals (HCP) considering the diagnosis of Autism Spectrum Disorder (ASD) in patients 18 months through 72 months of age at risk for developmental delay. The patient’s caregiver uses a smartphone application (“App”) to fill out a caregiver questionnaire and to make video recordings of behavior at home, and then the physician fills out a medical questionnaire online. The results are made available to the physician.
An interpretive, machine-learning-enabled software as a medical device (SaMD) application intended to be used to aid a healthcare professional in the diagnosis of a neurodevelopmental disorder (e.g., autism). It analyses patient demographics and questionnaire data from one or more sources (e.g., parent/caregiver, healthcare professionals) and provides an assessment. It is designed to be installed on an off-the-shelf device and intended primarily for use by a healthcare professional, however includes a parent/caregiver facing application.
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