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

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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.

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Best-in-class Accuracy

Proven accurate in a prospecitve clinical trial

Desktop

93.0

Sensitivity

91.4%

Specificity

Handheld

93.6%

Specificity

91.9% 

Sensitivity

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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.

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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

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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

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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

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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.

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.

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.

Our algorithm enables early detection, which can aid in dramatically slowing disease progression. Results for our best-in-class solution will be published imminently.

CAUTION: Federal (US) law restricts this device to investigational use only.

NOT SOLD IN THE US

See what people are saying about us

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The time has finally come for autonomous screening technology to exceed the efficacy of the human expert. The implications are that it can be practical for deployment on the front lines of population health – the primary care offices, where over 99% imageability and single image diagnostic acquisition are tantamount to market success

Sean Ianchulev

MD, MPH, CEO at Eyenovia. Professor of Ophthalmology at UCSF & Mt. Sinai

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