EarliPoint System
EarliTec Diagnostics
Measures a young child's visual attention to social stimuli using eye tracking, producing indices intended to aid autism diagnosis and severity assessment in children 16 to 30 months old.
At A Glance
- Manufacturer
- EarliTec Diagnostics
- Medical specialty
- Psychiatry and Behavioral Health
- Clearance route
- De Novo
- Year authorized
- 2022
- Modality
- Eye tracking
- Role in workflow
- Diagnostic aid
Behavioral diagnosis is normally an observational judgment, which makes it vulnerable to observer variability and to caregiver reporting bias. Eye tracking produces a measurement instead, and measurement is what the field has largely lacked.
Where It Is Used
- Early autism diagnostic support
- Objective measurement of social attention
- Severity indexing alongside clinical assessment
Limitations Worth Knowing
The indicated age band is narrow. The device measures social visual attention, which correlates with but is not identical to the diagnostic construct, and it remains an aid used alongside a clinical evaluation rather than a replacement for one.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.