FDA Clears Neurora Device To Support Autism Diagnosis In Children

The U.S. Food and Drug Administration (FDA) cleared Neurora, a prescription software device developed by Argus Cognitive, Inc., to help clinicians diagnose autism in children ages 18 months through 12 years. The device analyzes video and audio recordings from standard behavioral assessments to measure more than 100 vocal, facial, and eye-gaze characteristics. It is intended to support clinical judgment and cannot be used as a stand-alone diagnostic tool. A limited no-cost pilot is available for clinical professionals, but pricing beyond the pilot has not been disclosed.

Clinicians upload video and audio recordings from an existing behavioral . . .