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Benefits of Point-of-Care Screening
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Practical
Requires only one image per eye; rarely requires dilation
Accurate
Best-in-class efficacy proven in a pivotal prospective FDA study
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Simple to operate
Screening, taking only two minutes for most patients, can be done by any healthcare staff
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Reimbursable
Dedicated CPT code 92229
Closes Care Gaps
Closes the diabetic eye exam care gap for HEDIS/Star quality measures
How it works
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Image
A single image per eye is obtained using an indicated camera
Analyze
Images are analyzed by the AI
Result
Diagnostic result returned in under a minute
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Regulatory Approval
On November 2022, the FDA cleared the use of AEYE-DS for the detection of more-than-mild diabetic retinopathy with the Topcon NW400 camera
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Indications for Use
The AEYE-DS is indicated for use by health care providers to automatically detect-more-than-mild diabetic retinopathy (mtmDR) in adults 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.
Aurora AEYE
Cost-effective, compact fundus camera with built-in diagnostic screening intelligence
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Compact, cost-effective retinal camera with built-in diagnostic screening intelligence
Aurora AEYE is the first portable camera capable of screening for diabetic retinopathy
Ease of use combined with accurate AI make it the first practical screening solution for primary caregivers
NOT SOLD IN THE US
CAUTION: Federal (US) law restricts this device to investigational use only.
See it in Action
