Clinical Trial: Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy

U.S., Sept. 29 -- ClinicalTrials.gov registry received information related to the study (NCT07844317) titled 'Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy' on Sept. 14.

Brief Summary: Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.

Study Start Date: Aug. 24

Study Type: OBSERVATIONAL

Condition: Diabetic Retinopathy (DR)

Intervention: DEVICE: SaMD intended for the detection of diabetic retinopathy in adults with diabetes.

No significant difference to other SaMDs for the detection of DR that are commercialized.

DEVICE: An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in a...