- This clearance expands the label of its flagship product, the EyeArt® AI system, broadening the choice for primary care clinics to screen people with diabetes
- Company’s FDA clearance also includes Real-Time Image Quality Feedback and an upgraded image quality assessment module, achieving best-in-class gradability (conclusive reports) without eye dilation
LOS ANGELES, June 22, 2023 – Eyenuk, a global artificial intelligence (AI) digital health company, and the leader in real-world applications for AI Eye Screening™ and AI Predictive Biomarkers™, has received U.S. Food and Drug Administration (FDA) clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (DR), adding to the already-cleared usage with Canon CR-2 AF and Canon CR-2 Plus AF cameras.
The regulatory clearance of the EyeArt v2.2.0 system makes it the first and only AI system that is FDA-cleared for use with multiple retinal cameras by different manufacturers. This clearance builds upon the EyeArt system’s launch in August 2020 as the first and only AI technology to be cleared by the FDA to detect both more than mild and vision-threatening DR. In the European Union, the EyeArt system is the first and only AI system approved under MDR Class IIb to detect DR, age-related macular degeneration, and glaucomatous optic nerve damage, in a single test.
Since its launch in global markets, the EyeArt system has been used by hundreds of clinics to enable safe and reliable eye screening for over 230,000 patients with diabetes and counting.
“I am particularly thrilled about this clearance as it showcases our extraordinary commitment towards our mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases,” said Kaushal Solanki, PhD, Founder and CEO of Eyenuk. “The EyeArt system can now be used with multiple camera models in the U.S., which significantly expands access for patients who can be screened in their primary care doctor’s office for preventable blindness due to diabetes.”
This latest FDA clearance for the EyeArt v2.2.0 system is based on clinical data from a prospective multi-center clinical trial (ClinicalTrials.gov ID NCT04984200) that demonstrated exceptional performance for the Topcon NW400 cameras, as summarized below.
- 94.4% sensitivity and 91.1% specificity for more than mild DR detection, and
- 96.8% sensitivity and 91.6% specificity for vision-threatening DR detection
Additionally, with this clearance, the EyeArt system gets an upgraded image quality assessment module and Eyenuk’s proprietary Real-Time Image Quality Feedback solution. These enhancements improve the EyeArt system’s usability, achieving the best-in-class gradability (i.e., percentage of patients with conclusive reports) without the need for dilation.
In the clinical trial, for all camera models (Canon CR-2 AF, Canon CR-2 Plus AF, and Topcon NW400) conclusive EyeArt results were available for 90.4% of cases without needing dilation and for 99% of cases when a small fraction was dilated after the quality feedback solution recommended dilation.
“I am excited that we are bringing several patient- and clinic-friendly product updates to the market through this clearance,” said Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs for Eyenuk. “Real-Time Image Quality Feedback can significantly improve the clinical workflows associated with diabetic eye exams, and achieving best-in-class gradability implies much better patient experience and saving of clinic staff time that otherwise would have been spent on dilation.”
Eyenuk will showcase the newly-cleared EyeArt system at the 83rd Annual Scientific Sessions of the American Diabetes Association (ADA 2023) on June 23–26 in San Diego, CA. Demonstrations will be available at booth #527.
About Eyenuk, Inc.
Eyenuk, Inc. is a global artificial intelligence (AI) digital health 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.
About the EyeArt AI System
The EyeArt AI system provides fully autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage, including retinal imaging, based on international clinical standards and immediate reporting, in a single office visit during a patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the detection results are available in a PDF report in less than 30 seconds.
The EyeArt AI system was developed with funding from the U.S. National Institutes of Health and is validated by the U.K. National Health Service. The EyeArt AI system has CE marking as a class IIb medical device in the European Union under the EU’s Medical Devices Regulation 2017/745 (“MDR”) for the detection of DR, AMD, and glaucomatous optic nerve damage. Additionally, the system has U.S. Food and Drug Administration 510(k) clearance and a Health Canada license for autonomous detection of DR. It is designed to be General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant.
The EyeArt AI system is reimbursable by government and private payors in the U.S. under the Category 1 Current Procedural Terminology (CPT) code 92229.