Autonomous diabetic retinopathy screening in primary care
El texto se muestra en inglés hasta que exista una traducción.
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.
Entorno clínico
Primary care and endocrinology clinics that can take retinal photographs during a diabetes visit, with referral to eye care when the result is positive.
Herramientas y proveedores
LumineticsCore (IDx-DR)
Digital Diagnostics
Topcon NW400
Lo que informó la fuente
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.
Fuente
U.S. FDA De Novo DEN180001 · 11 abr 2018 · Año 2018
The MASAI trial in Sweden randomly assigned screening mammograms to AI-supported reading or standard double reading without AI. Transpara scored each exam and routed lower scores to a single reader and the highest score to double reading, with detection marks available on higher-risk exams. This card quotes the prespecified interim safety analysis, not a claim that every screening program should switch.
Several cleared products flag possible urgent findings on a chest radiograph, such as pneumothorax, and move that study up a reading worklist. Names often cited for this job include Lunit INSIGHT CXR, Annalise Enterprise CXR, and qXR. This card describes the shared workflow, not a head-to-head, and it does not pool accuracy numbers across vendors. A flagged study still needs a radiologist’s report.
Viz.ai ContaCT analyzes brain CT angiography and can text a neurovascular specialist when it suspects a large-vessel occlusion, in parallel with the usual read. FDA permitted marketing in 2018 as notification software. The specialist still reviews full images on a diagnostic workstation. The product is not a diagnosis and not a treatment decision.