Canvas Dx 1.9.4

Canvas Dx is the initial and solitary FDA-authorized Software as a Medical Device (SaMD) designed to assist healthcare professionals in diagnosing autism spectrum disorder (ASD) in young children. Leveraging clinically validated artificial intelligence (AI) technology, Canvas Dx supports physicians in the diagnostic process for ASD in children aged 18-72 months who are at risk for developmental delay.

Three distinct and user-friendly inputs are integrated into Canvas Dx:

1. A parent/caregiver questionnaire, established through a dedicated app, inquiring about the child's behavior and development.
2. A questionnaire completed by video analysts who assess two parent/caregiver-recorded videos of the child.
3. An HCP questionnaire filled out by a physician following an evaluation with the child and parent/caregiver, facilitated through a dedicated healthcare provider portal.

The Canvas Dx algorithm processes all three inputs, producing an output for the physician to utilize in conjunction with their clinical expertise. It should be emphasized that Canvas Dx is not meant to serve as a standalone diagnostic tool but rather as a supplement to the diagnostic procedure, intended for prescription use only.

Contact Information:
Email: connect@cognoa.com
Phone: 1.866.4COGNOA (1.866.426.4662)

Indications for Use:
Canvas Dx is designed for use by healthcare providers to assist in diagnosing ASD in patients between 18-72 months who exhibit risk factors for developmental delay based on concerns raised by a parent, caregiver, or healthcare provider. It is not intended as a solo diagnostic method but as an aid during diagnosis and is strictly available by prescription (Rx only).

Contraindications:
There are no contraindications for using Canvas Dx.

Precautions and Warnings:

• The device is exclusively intended for use by healthcare professionals with the requisite training to interpret behavioral assessment results and diagnose ASD.
• It is recommended to use the device alongside patient history, clinical observations, and any additional clinical evidence deemed necessary by the healthcare provider before making diagnostic decisions.
• In cases where the output is inconclusive for ASD, further standardized testing may be necessary to validate the results.
• Canvas Dx is designed for patients whose caregivers are proficient in English (8th-grade reading level or above) and have access to a compatible smartphone with internet connectivity at home.
• The device might yield inaccurate results if used on patients with specific exclusionary conditions, including but not limited to those listed.
• The evaluation utilizing Canvas Dx should be conducted within 60 days of prescription due to the rapid neurodevelopmental changes characteristic of the specified age group.