Digital Diagnostics, Inc.
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Inclusion Criteria: * 22 years of age or older * Diagnosis of DM * Ability to understand and willing to sign a written ICF Exclusion Criteria: Participants may be excluded if they have significant ocular conditions or prior ocular treatments that could interfere with retinal imaging or study assessments; are currently participating in another interventional ophthalmic clinical trial; have medical conditions that may affect study participation or data interpretation; are pregnant; or have contraindications to study-related imaging procedures.
No significant difference to other SaMDs for the detection of DR that are commercialized.
SaMD to detect diabetic retinopathy
Arctuva estimate
Verify or correct the compensation shown for this listing.