Autonomous diabetic retinopathy screening in primary care
IDx-DR, now marketed as LumineticsCore by Digital Diagnostics, was authorized to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photo first. A primary care team captures images on a specified retinal camera and the software returns a refer-or-rescreen result. It is not a complete eye examination. Pregnancy and several existing retinal conditions sit outside the labeled use.
Clinical setting
Primary care and endocrinology clinics that can take retinal photographs during a diabetes visit, with referral to eye care when the result is positive.
Tools and vendors
LumineticsCore (IDx-DR)
Digital Diagnostics
Topcon NW400
What was reported
In the study FDA reviewed (900 patients, 10 primary care sites), the system correctly identified more-than-mild diabetic retinopathy 87.4% of the time and correctly identified patients without it 89.5% of the time.
Source
U.S. FDA De Novo DEN180001 · Apr 11, 2018 · Year 2018
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