BREAKING NEWS: FDA clears AEYE’s autonomous screening system for diabetic retinopathy featuring groundbreaking diagnostic accuracy, >99% imageability and using only one image per eye
Redefining Autonomous Diagnostic Screening
We’re applying our AI expertise to retinal imaging to deliver broad diagnostic screening solutions that address care gaps in primary care
AEYE Diagnostic Screening
AEYE Diagnostic Screening (AEYE-DS) utilizes Artificial Intelligence (AI) technology to diagnose diabetic retinopathy from retinal images.
First to be proven accurate on both a stationary desktop camera and a portable handheld camera
AEYE with TOPCON
AURORA AEYE
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NOT SOLD IN THE US
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CAUTION: Federal (US) law restricts this device to investigational use only.
Best-in-class Accuracy
Proven accurate in a prospecitve clinical trial
Desktop
93.0%
91.4%
Sensitivity
Specificity
Handheld
93.6%
Specificity
91.9%
Sensitivity
The Only Practical Solution
Requires one images per eye;
rarely requires dilation
handheld & desktop
1 Image
Per eye
Imageability
>99%
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Accessible
Enables point-of-care screening instead of referring to a specialist.
Reimbursement code
CPT 92229
Measure 117
HEDIS Quality Measure
Over 35M
people with diabetes in the US and 422M worldwide are at risk of sight-threatening diabetic retinopathy.
85%
of people with diabetes over 40 will develop diabetic retinopathy.
Why it matters
Screening Prevents Blindness
Accessible and affordable screening for diabetic retinopathy is vital to help ensure patients with diabetes receive sight-saving treatment.
Only 15% to 50%
of patients with diabetes in the US adhere to the recommended screening.
Why It Matters
Screening prevents blindness
Accessible and affordable point-of-care screening for diabetic retinopathy is vital to help ensure people with diabetes receive sight-saving treatment.
Before
After
Benefits of
Point-of-Care Screening
Practical
Requires only one image per eye; rarely requires dilation
Accurate
Best-in-class efficacy proven in a pivotal prospective FDA study
Simple to operate
Can be operated by primary care personnel with no prior experience
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Reimbursable
Dedicated CPT code 92229
Closes Care Gaps
Closes the diabetic eye exam care gap for HEDIS/Star quality measures
Diabetic Retinopathy
Best-in-class accuracy
Published results
Diabetic retinopathy is the leading cause of blindness in working-age adults in the US.
Our FDA-cleared technology enables accessible early detection, which can save the sight of millions.
Our Mission
Autonomous comprehensive diagnostic screening for a broad range of diseases using retinal images
Diabetic Retinopathy
Best-in-class accuracy
Published results
Diabetic retinopathy is the leading cause of blindness in working-age adults in the US.
Our FDA-cleared technology enables accessible early detection, which can save the sight of millions.
Glaucoma
Best-in-class accuracy
Published results
Glaucoma is the second most common cause of blindness worldwide.
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Our algorithm enables early detection and accessible screening, encouraging timely and effective treatment. Our results are also the first to show high agreement with eye doctors.
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Age-related Macular Degeneration (AMD)
Best-in-class accuracy
Publication coming soon
Age-related Macular Degeneration is an extremely common condition which impairs sharp central vision.
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Our algorithm enables early detection, which can aid in dramatically slowing disease progression. Results for our best-in-class solution will be published imminently.