Neurodevelopmental disorder interpretive software

Definition
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.
GUDID devices
2
Last updated
2023-08-03 06:24:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00860009993709EarliPointEarlitec Diagnostics, Inc.EPT0012023-07-26
00860007260605Canvas DxCognoa, Inc.1.1.02021-12-08