Source record
Autonomous diabetic retinopathy screening in primary care
El texto se muestra en inglés hasta que exista una traducción.
The source is the U.S. FDA De Novo decision DEN180001 for IDx-DR, now marketed as LumineticsCore, dated 11 April 2018. It authorizes autonomous screening of adults with diabetes for more-than-mild diabetic retinopathy, using a specified retinal camera, without a clinician reading the image first. FDA’s review describes a study of 900 patients at 10 primary care sites, with sensitivity 87.4% and specificity 89.5% for more-than-mild diabetic retinopathy. The decision is a device authorization, not a claim that the software replaces a full eye examination.
- Source date
- 11 abr 2018 · Año 2018
- Evidence label
- Regulatorio
- Source type
- Noticia
Citation
U.S. FDA De Novo DEN180001
U.S. Food and Drug Administration. De Novo classification request DEN180001, IDx-DR (marketed as LumineticsCore by Digital Diagnostics). Decision date 11 April 2018. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN180001
Key public facts
- FDA authorized the system on 11 April 2018 to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photograph first.
- The pathway uses a specified retinal camera. This index names the Topcon NW400 among the configurations associated with the product.
- The output is a refer-or-rescreen result. It is not a complete eye examination.
- Pregnancy and several existing retinal conditions sit outside the labeled use.
- In the study FDA reviewed, 900 patients were enrolled at 10 primary care sites. Sensitivity for more-than-mild diabetic retinopathy was 87.4%, and specificity was 89.5%.
Ficha para educación y lectura de mercado. No es consejo médico ni un aval.