Eyenuk Announces FDA Clearance for EyeArt Autonomous AI System for Diabetic Retinopathy Screening
Eyenuk, Inc., a global artificial intelligence (AI) medical technology and 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.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200805005495/en/
EyeArt AI System (Eyenuk, Inc.) (Photo: Business Wire)
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.
About the EyeArt® AI System
The EyeArt AI Eye Screening System provides fully automated DR screening, including retinal imaging, DR grading on international standards and immediate reporting, in a single office visit during a diabetic patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the DR screening results are available in a PDF report in less than 60 seconds. EyeArt’s FDA cleared indications for use in the U.S. is below.
EyeArt is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy (severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and/or diabetic macular edema) in eyes of adults diagnosed with diabetes who have not been previously diagnosed with more than mild diabetic retinopathy. EyeArt is indicated for use with Canon CR-2 AF and Canon CR-2 Plus AF cameras in both primary care and eye care settings.
The EyeArt AI System was developed with funding from the U.S. National Institutes of Health (NIH) and is validated by the U.K. National Health Service (NHS). In addition to US FDA clearance, the EyeArt AI System has CE marking as a class 2a medical device in the European Union and a Health Canada license. It is designed to be General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant.
About Eyenuk, Inc.
Eyenuk, Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screening for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk and Alzheimer’s disease. Find Eyenuk online on its website, Twitter, Facebook, and LinkedIn.
2 Y. Zheng, M He, and N Congdon. The worldwide epidemic of diabetic retinopathy. Indian J Ophthalmol. 2012 Sept-Oct; 60(5): 428-431.
3 International Diabetes Federation. IDF Diabetes atlas, Sixth edition, Brussels, Belgium. 2015.
4http://www.icoph.org/ophthalmologists-worldwide.html and https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf
Eyenuk, Inc. Contact
Frank Cheng, President & CCO
+1 818 835 3585
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward26.10.2020 20:05:00 CET | Press release
PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.cisbio.eu%2Fphospho-ubiquitin-ser65-cellular-kit-44930&esheet=52314112&newsitemid=20201026005820&lan=en-US&anchor=new+PerkinElmer+Cisbio+HTRF%26%23174%3B+Phospho-Ubiquitin+%28Ser65%29+Cellular+Kit&index=2&md5=c03392c571335691d83031ec057300f1 new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle. The innovative assay leverages TR-FRET technology to bring high sensitivity
NetApp Brings Optimization and Enterprise Data Services to the Cloud26.10.2020 17:00:00 CET | Press release
Global, cloud-led, data-centric software company NetApp® (NASDAQ: NTAP) today unveiled a groundbreaking serverless and storageless solution for containers from Spot by NetApp, a new autonomous hybrid cloud volume platform, and cloud-based virtual desktop solutions. NetApp’s new capabilities help simplify and optimize multicloud management for the highest performance at a low cost, offering true portability for data-rich cloud applications and delivering comprehensive workplace solutions across hybrid cloud environments. “To thrive in the new normal, digital transformation has become a business imperative. To succeed, businesses need to optimize their hybrid multicloud IT architectures,” said NetApp CEO George Kurian. “No matter where customers are on their transformation journey, NetApp can help them build a data fabric to maximize the value of their data, ensure applications are running optimally, and unlock the best of cloud.” The new features and capabilities that NetApp introduced
omni:us Welcomes Insurance Veteran Antonio Derossi to Drive Growth Across US and Europe26.10.2020 16:00:00 CET | Press release
omni:us, the insurance claims AI solution provider, welcomes Antonio Derossi as a member of the omni:us Senior Executive Advisory board. Mr. Derossi, with 20+ years of experience in various roles across insurance, consulting, and venture capital, will function as a key advisor on go-to-market and product optimization strategies for the North American and European insurance markets. omni:us seeks to fortify its position as global pioneer of insurance claims transformation with the expert support of Mr. Derossi. Both parties see automation as a defining element of future claims management systems. Mr. Derossi’s understanding of the intricacies of the American and European insurance space will support increased market penetration for the Berlin-based omni:us. He will also act as an effective liaison to insurance companies, solution providers and consulting partners across both continents. Derossi was born in Trieste, Italy. He holds a Laurea degree in physics from Trieste University, and
Dahua Sponsors Omdia Webinars on Next Generation Network Cameras26.10.2020 14:45:00 CET | Press release
Dahua Technology, a world-leading video-centric smart IoT solution and service provider, has sponsored one white paper and two webinars hosted by Omdia. The theme of the webinars held on October 22nd is Solving security challenges: Next-generation network cameras. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005466/en/ (Photo: Business Wire) Omdia is the new global technology research powerhouse, established in 2019 with the combination of the Informa Tech’s research brands (Ovum, Heavy Reading, and Tractica) and the acquired IHS Markit technology research portfolio. Collaborating with Dahua Technology, the comprehensive webinar has attracted about 1200 registrations. Audiences are experts from various industries such as energy, finance, education, government, retail, etc. With webinar events experts from Omdia, Dahua Technology’s Senior Project Sales Manager Simon Nash and Omdia’s analysts Josh Woodhouse and Tommy Z
26 th Yiwu Fair Concludes with Success, Reaching Deals Worth Millions in Small Commodities26.10.2020 14:36:00 CET | Press release
The 26th China Yiwu International Commodities (Standards) Fair concluded in Yiwu on October 25, 2020. As the first large-scale foreign trade exhibition presented both online and offline in China amid regular epidemic prevention and control, Yiwu Fair 2020 provided more than 3,400 standard booths with an exhibition area of 100,000 square meters at the Yiwu International Expo Center, and attracted nearly 2,000 companies from 19 domestic provinces, municipalities and autonomous regions, covering categories of hardware, electromechanical facilities, electronic & electrical appliances, daily necessities, crafts & ornaments, stationery & office goods, toys, sporting & outdoor products, knitwear, and gift packaging. The Fair attracted a total of 106,000 offline visitors and 160 million online views. Seven overseas online matchmaking sessions were held targeting the United Kingdom, Malaysia, Chile, etc., and achieved an intended turnover of $4.66 million. While expanding the international ma
Interactive Brokers Launches Innovative Sustainable Investing Tool26.10.2020 14:18:00 CET | Press release
Interactive Brokers Group (Nasdaq: IBKR), a global brokerage firm, today unveiled an innovative, interactive Impact Dashboard designed to help clients evaluate and invest in companies that align with their values. The dashboard, which is free for all clients to use, sets a new standard for tools that can be used for sustainable, socially responsible, and values-based investing. The launch comes as interest in Environmental, Social and Governance (ESG) investing is soaring. ESG assets are expected to top $53 trillion by 2022, according to research released in September by Celent. “The future of sustainable investing begins with the Impact Dashboard, which allows investors to align their portfolios with their values,” said Will Peterffy, ESG Director at Interactive Brokers. “In a world lacking transparency, the dashboard quickly analyzes and grades your stock portfolio based on your values and presents your holdings through a personalized ‘impact lens’. You can then decide whether to kee
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom