Neurology
EarliPoint Assessment
Earlitec Diagnostics
FDA-cleared AI medical device
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
FDA Submission Metadata
- Submission number
- K253442
- Decision date
- March 2026
- FDA panel
- Neurology
- Product code
- QPF
This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.
This entry is on our editorial review queue. Full evaluation — performance metrics, clinical evidence, safety record — lands as our review pipeline graduates each device. The information above is what's been verified to date.