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नियामकसमाचार

Autonomous diabetic retinopathy screening in primary care

अनुवाद आने तक यह लेख अंग्रेज़ी में है।

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.

नैदानिक परिस्थिति

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

उपकरण और विक्रेता

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

स्रोत ने क्या बताया

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.

स्रोत

U.S. FDA De Novo DEN180001 · 11 अप्रैल 2018 · वर्ष 2018

सूचकांक में जोड़ा गया 12 अग॰ 2026

स्रोत खोलें

टैग

  • जांच
  • नियमन
  • कंप्यूटर दृष्टि

शिक्षा और बाज़ार देखने की प्रविष्टि। चिकित्सा सलाह या समर्थन नहीं।

इमेजिंग और रेडियोलॉजी

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Transpara 1.7.0 · ScreenPoint Medical

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