Eyenuk Inc. Receives Health Canada Approval for EyeArt

Eyenuk Inc., a developer of advanced artificial intelligence (AI) enabled, clinically supported solutions to identify diseases via retinal image analysis, has received a Medical Device License from Health Canada for its AI-enabled cloud-based diabetic retinopathy (DR) automated screening software system, EyeArt (v2.1.0). The license allows Eyenuk to begin commercializing EyeArt and begin sales throughout Canada.

Building upon Eyenuk’s successful launch in Europe, this Health Canada license supports Eyenuk’s objective to expand the global availability of EyeArt to more clinicians seeking tools for improved screening of diabetic retinopathy in their patients at the point of care.
 
A key breakthrough that EyeArt brings to clinics in Canada (and Europe) is that the software is indicated for use by health care professionals including nurses or technicians, and does not require expert human grading or an over-read from an eye care specialist. EyeArt™ screening software is designed to return results within 60 seconds and work with most fundus cameras that provide quality images. With EyeArt, Eyenuk aims to make available a cost-effective approach to diabetic retinopathy screening that can be deployed at mass scales in the primary health care setting.

Learn more about EyeArt by watching the video below:

 

“We are very excited to launch the EyeArt screening software in Canada, building upon our impressive clinical results from Europe,” said Kaushal Solanki, founder and CEO of Eyenuk.“ Access to eye screening is limited and expensive for many patients and as a result diabetic retinopathy is the leading cause of preventable blindness, especially impacting working-age adults across the world. We are proud to expand EyeArt to additional countries in an effort to make diabetic eye screening more accessible, more efficient, and less expensive, thereby reducing the number of patients losing vision as a complication of diabetes.”
 
EyeArt has CE marking in the European Union. The technology is currently being used commercially in Europe and as an investigational device at prestigious clinical institutions across the United States.
 
In addition to receiving the Canadian Medical Device License, Eyenuk executives said the company’s quality management system has been registered by Intertek Testing Services NA Inc., a Medical Device Single Audit Program recognized auditing organization, as conforming to the requirements of ISO 13485:2003 for the design and development, product, installation and service of stand-alone image analysis software for retinal diseases or disorders.

Diabetic retinopathy (DR) is a blinding eye disease which can affect many of the 415 million patients living with diabetes worldwide. Vision loss due to DR is preventable, if diagnosed early through annual eye screening. However, in many places the current number of eye care professionals cannot keep pace with the demand for annual eye screening, making DR the leading cause of blindness among working-age adults in the industrialized world. Experts have recognized that the only feasible way to address this issue is to efficiently expand DR screening in the primary care environment via computerized analysis.
 
Eyenuk Inc., headquartered in Los Angeles, Calif., is an AI diagnostic company focused on quickly and accurately identifying patients suffering from potentially blinding eye diseases and chronic diseases at the point of care. Using computer vision and machine learning expertise, the company is developing a portfolio of products based on its proprietary retinal image analysis technology combined with deep learning to identify and track the progression of diseases including diabetic retinopathy, glaucoma, age-related macular degeneration, risk of stroke, cardiovascular risk, and Alzheimer’s disease.
 
Eyenuk’s first product to market, EyeA rt, is a fully-automated cloud-based software device for screening of diabetic retinopathy, the leading cause of blindness in working- age adults. In the United States, EyeArt is limited by federal law to investigational use only and is not available for sale.EyeArt is a trademark of Eyenuk Inc.