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規制ニュース

Autonomous diabetic retinopathy screening in primary care

この言語の本文は未訳のため、英語で表示しています。

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.

臨床の場

Primary care and endocrinology clinics that can take retinal photographs during a diabetes visit, with referral to eye care when the result is positive.

ツールとベンダー

  • LumineticsCore (IDx-DR)
  • Digital Diagnostics
  • Topcon NW400

出典が報告したこと

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.

出典

U.S. FDA De Novo DEN180001 · 2018年4月11日 · 年 2018

索引への追加 2026年8月12日

出典を開く

タグ

  • 検診
  • 規制
  • コンピュータビジョン

教育と市場把握のための条目。医療助言でも推奨でもありません。

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