Bipolar Disorder Test vs Canvas Dx

Bipolar Disorder is a mental disorder that causes shifts in a person's mood, energy, and thoughts. People with bipolar disorder experience high and low moods (mania and depression, respectively) that are more extreme than what people typically experience. This can lead to a lot of stress and problems with family, work, money, and the law. This app contains a self-report questionnaire to help screen for symptoms related to bipolar disorder. It also contains information to help you get a better understanding of this mental illness. Bipolar Disorder Test is designed to evaluate your symptoms of bipolar disorder with a scientifically-supported 15-question test. It uses the Mood Disorder Questionnaire (MDQ), a screening questionnaire for bipolar spectrum disorder that is commonly used in research and healthcare settings. Bipolar Test contains four tools: - Start Test: take the MDQ questionnaire to screen for bipolar disorder - Result: understand your test results and get resources tailored to your result - Information: learn about bipolar spectrum disorder and discover additional resources that can help you on your path to recovery Disclaimer: The MDQ is NOT a diagnostic test. A diagnosis can only be provided by a qualified healthcare professional. Please consult a physician or mental health professional if you are concerned about bipolar disorder.  References: Hirschfeld, R. M., Williams, J. B., Spitzer, R. L., Calabrese, J. R., Flynn, L., Keck Jr, P. E., ... & Russell, J. M. (2000). Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. American Journal of Psychiatry, 157(11), 1873-1875.

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.