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AEYE Diagnostic Screening (AEYE - DS)

Autonomous Screening for
Diabetic Retinopathy (DR)

The first practical point-of-care screening solution for diabetic retinopathy

How it works

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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Benefits of Point-of-Care Screening

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Practical

Requires only one image per eye; rarely requires dilation

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Accurate

Best-in-class efficacy proven in a pivotal prospective FDA study

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Simple to operate

Can be operated by primary care personnel with no prior experience

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Reimbursable

Dedicated CPT code 92229

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Closes Care Gaps

Closes the diabetic eye exam care gap for HEDIS/Star quality measures

Compatible Retinal Cameras

Topcon AEYE

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Automated fundus camera combined with autonomous diagnostics technology

 

Robotic camera can automatically capture images


No lock-in contracts

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

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.

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
 
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