Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening

Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening

 

 

EyeArt is the First FDA Cleared AI Technology for

Autonomous Detection of Both More than mild and Vision-

Threatening Diabetic

Retinopathy

     Eyenuk, Inc   a global artificial intelligence (AI) medical technology an   .,  

,services company and the leader in real-world applications

for AI Eye Screening, announced today that it has received

510(k) clearance (K200667) by the U.S. Food & Drug

Administration (FDA) to market its EyeArt® autonomous AI

System for diabetic retinopathy, a leading cause of

blindness among American adults.

EyeArt is indicated for use by healthcare providers to

automatically detect more than mild diabetic retinopathy

(mtmDR) and vision-threatening diabetic retinopathy

(vtDR) in eyes of adults diagnosed with diabetes who have

not been previously diagnosed with more than mild diabetic

retinopathy. EyeArt is the first FDA cleared autonomous AI

technology that can detect both mtmDR and vtDR in one

test, in primary care and eye care settings. In addition,

EyeArt is also the first FDA cleared autonomous AI

technology that has diagnostic outputs for each eye of a

patient.

Diabetic retinopathy (DR) is a common complication of

diabetes. It is characterized by progressive damage to the

blood vessels of the retina, the light-sensitive tissue at the

back of the eye that is necessary for good vision. According

to CDC, an estimated 4.1 million and 899,000 Americans

are affected by retinopathy and vision-threatening

retinopathy, respectively.¹ It is estimated that number of

vision-threatening diabetic retinopathy patients around the

world will reach 56.3 million by 2030.²

While DR screening is recommended for all diabetic

patients, less than half get screened annually³, even in the

developed world. Since more than 30 million Americans

have diabetes and diabetic patients outnumber

ophthalmologists by 1,600 to 1 in the U.S.,⁴ there are just

not enough eye care specialists to meet the DR screening

needs of the growing diabetic population. Even for those

receiving their annual screening, ophthalmology

appointment wait times for DR screening can be weeks or

even months. Since pharmaceutical and surgical

therapeutics can effectively prevent DR related blindness

when patients are identified and treated on a timely basis,

offering convenient and reliable DR screening without over-

burdening eyecare professionals has become a top priority

of governments, health systems and payors around the world.

The EyeArt 510(k) clearance is based on a pre-registered,

prospective, multi-center pivotal clinical trial

(ClinicalTrials.gov ID NCT03112005). A total of 942

participants were consented of which 915 participants met

study eligibility criteria. Of the 655 participants aligned for

analysis to establish substantial equivalence, 380 were

enrolled at 7 primary care sites and 275 were enrolled at 4

ophthalmology sites. Study participants underwent 2-field

retinal photography for analysis by the EyeArt system. They

then underwent dilated four wide field stereo retinal

photography for the reference standard which was

determined by expert graders at the Fundus Photography

Reading Center (FPRC), according to the Early Treatment

for Diabetic Retinopathy Study severity (ETDRS) scale. The

rigorous ETDRS reference standard implemented by a

reading center such as FPRC is typically only used in clinical

trials and not feasible in clinical practice due to its

significant requirements for time and resources.

EyeArt’s FDA clearance was based on analysis of EyeArt

performance in participants enrolled at primary care and

general ophthalmology sites during a period of time where

enrollment was sequential and also during a period where

sites were permitted to enrich the study population. The

sequential enrollment allows for an unbiased

representation of the US diabetic population and provides

the following topline results from this pivotal clinical trial.

 

• 96% sensitivity and 88% specificity for detecting mtmDR
• 92% sensitivity and 94% specificity for detecting vtDR
• All eyes with ETDRS level 43 or higher were correctly identified as mtmDR positive

The study also showed that novice operators can be trained

to obtain medical grade retinal images. Even at primary

care centers where most operators did not have prior

ophthalmic imaging experience, EyeArt had an imageability

of 97% (i.e., disease detection results were provided for

97% of eyes that received a reading center grading).

Moreover, a vast majority of participant eyes (90%)

received disease detection results without needing dilation.

“This is great news to over 30 million Americans living with

diabetes, especially those who may have vision-threatening

diabetic retinopathy. The EyeArt autonomous AI System

can now enable safe, effective, and equitable diabetic eye

screening at convenient point-of-care locations, with AI

results available in less than 1 minute,” said Kaushal

Solanki, Ph.D., founder and CEO of Eyenuk. “This historical

FDA clearance is our first major milestone enabled by our

prospective, multi-center pivotal clinical trial which took us

years to plan and complete.”

The EyeArt system is indicated for use with two models of

fundus camera in the U.S., Canon CR-2 AF and Canon CR-2

Plus AF. Eyenuk plans to expand the list of EyeArt-

compatible imaging devices, by leveraging Eyenuk’s deep

expertise in device validation, clinical research, and

regulatory process in markets around the world.

Autonomous AI for diabetic retinopathy screening will

likely be covered by payors starting 2021. In May 2019, the

AMA CPT Editorial Panel created new CPT code 9225X

(Imaging of retina for detection or monitoring of disease;

with point-of-care automated analysis with diagnostic

report; unilateral or bilateral) for point-of-care automated

analysis that uses innovative AI technology to perform the

interpretation of the eye exam, without requiring that an

ophthalmologist interpret the results. Medicare is

considering CPT code 9225X to be a diagnostic service

under the Physician Fee Schedule and is creating separate

payment for it.