Canvas Dx 1.9.3
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Free Version
Publisher Description
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.
Mar 4, 2024
Version 1.9.3
- Fixes the display of some errors.
About Canvas Dx
Canvas Dx is a free app for iOS published in the Health & Nutrition list of apps, part of Home & Hobby.
The company that develops Canvas Dx is Cognoa, Inc.. The latest version released by its developer is 1.9.3.
To install Canvas Dx on your iOS device, just click the green Continue To App button above to start the installation process. The app is listed on our website since 2024-03-04 and was downloaded 0 times. We have already checked if the download link is safe, however for your own protection we recommend that you scan the downloaded app with your antivirus. Your antivirus may detect the Canvas Dx as malware if the download link is broken.
How to install Canvas Dx on your iOS device:
- Click on the Continue To App button on our website. This will redirect you to the App Store.
- Once the Canvas Dx is shown in the iTunes listing of your iOS device, you can start its download and installation. Tap on the GET button to the right of the app to start downloading it.
- If you are not logged-in the iOS appstore app, you'll be prompted for your your Apple ID and/or password.
- After Canvas Dx is downloaded, you'll see an INSTALL button to the right. Tap on it to start the actual installation of the iOS app.
- Once installation is finished you can tap on the OPEN button to start it. Its icon will also be added to your device home screen.
