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Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
Sponsor: Digital Diagnostics, Inc.
Summary
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Official title: A Multicenter, Prospective Clinical Trial to Evaluate the Safety and Efficacy of an Automated System for Detecting Diabetic Retinopathy Using a Fundus Camera
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
800
Start Date
2026-08-24
Completion Date
2027-08-31
Last Updated
2026-09-28
Healthy Volunteers
Yes
Conditions
Interventions
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.
An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
SaMD to detect diabetic retinopathy
Locations (1)
Rovia Site Network
Jacksonville, Florida, United States