AEYE Diagnostic Screening Updated Image

Diabetic Retinal Screening

  • RAutomated fundus camera combined with autonomous diagnostics technology
  • RRobotic camera can automatically capture images
  • RNo lock-in contracts
Regulatory Approval

The Topcon desktop was approved in November of 2022 and the Aurora IQ handheld was approved in April of 2024

Indication for Use

The AEYE-DS is indicated for use by health care providers to automatically detect-more-than-mild diabetic retinopathy (mtmDR) in adults (22 years of age or older) diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.

Accuracy & Usability

In an FDA clinical study for the detection of more-than-mild diabetic retinopathy, the AEYE-DS was found to have 93% sensitivity and over 91.4% specificity using one image per eye captured using the Topcon NW400.

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