HCPlive (6/2, Iopace) reports the FDA “has granted de novo clearance” to Cognoa “for an AI-based, diagnostic aid (Canvas Dx) designed to aid physicians in primary care” in making a “diagnosis of autism.” This clearance “is the first authorized to aid in primary care diagnosis of autism in young children, with the goal of shortening time-to-diagnosis and initiation of earlier interventions.” The diagnostic aid “is indicated for use in diagnosis of autism spectrum disorder for patients aged 18 to 72 months at risk of developmental delay, based on concerns from parent, caregiver, or” clinician.
Related Links:
— “FDA Grants De Novo Clearance to AI-Based Autism Diagnosis Aid “Connor Iapoce, HCPlive, June 2, 2021