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監管授權新聞

Autonomous diabetic retinopathy screening in primary care

此語言的正文尚未翻譯,暫以英文顯示。

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.

臨床場景

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

工具與廠商

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

來源中報告了什麼

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.

來源

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

收入索引 2026年8月12日

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