Optomed News
Optomed Releases First FDA-Cleared Handheld AI Fundus
Camera for Detection of Diabetic Retinopathy
Optomed USA, Inc. introduces the Optomed Aurora AEYE, the first FDA-cleared handheld AI fundus camera designed for detection of more than mild diabetic retinopathy.
This innovative device enables immediate eye screenings, providing results in about 60 seconds. Clinical trials have shown diagnostic sensitivity ranging from 92% to 93%, specificity from 89% to 94%, with over 99% of patients receiving a diagnostic result.
With its non-mydriatic operation and high-contrast optical design, the camera can detect early-phase retinal changes with a 50-degree field-of-view. Its ease-of-use features include autofocus and auto exposure functions, facilitating quick and accurate screenings.
The Optomed Aurora AEYE aims to address the significant gap in diabetic retinopathy screenings in the US by enabling providers to detect diabetic retinopathy on-the-spot, improving clinic adherence to standards, and ultimately preventing blindness in at-risk diabetic patients.
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