Neurology
EarliPoint Assessment
EarliTec Diagnostics, Inc.
FDA
FDA-cleared AI medical device
Eye-tracking-based assessment that measures a child's moment-by-moment visual attention to social information while watching short video scenes, intended to aid qualified clinicians in the diagnosis and assessment of autism spectrum disorder in children aged 16 through 95 months.
FDA Submission Metadata
- Submission number
- K253442
- Decision date
- March 2026
- FDA panel
- Neurology
- Product code
- QPF
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA