AI systems expand the availability of vision-saving eye screening by enabling automated AI diagnosis and care coordination in primary care practices without the need for expert review.
Eyenuk has been approved to market its AI eye screening system (EyeArt) in the European Union for new applications in detecting age-related macular degeneration (AMD) and glaucomatous optic nerve damage (glaucoma).
The AI system (version 3.0) has received the new European Commission (EC) certification as a Class IIb medical device under the EU Medical Device Regulation 2017/745 (“MDR”) and has been approved for diabetic retinopathy (DR). It is intended to detect signs of (including diabetic macular edema), AMD, and glaucoma in patients at risk of blindness using computerized analysis of retinal images. This system was previously approved in the EU for the detection of DR.
According to the company, this EC certification makes its AI system the first and only autonomous AI solution with a Class IIb MDR CE marking for automatic detection of all three eye diseases, making Eyenuk’s EU customers one-time will be able to detect these diseases. Test using the same set of retinal images.
The company also says its AI system is now CE marked for the detection of three diseases and is the only FDA cleared for the detection of DR, the leading cause of blindness in working-age adults. said to be a system.
AI systems expand the availability of vision-saving eye screening by enabling automated AI diagnosis and care coordination in primary care practices without the need for expert review. The system is integrated with a retinal imaging camera and can be operated by clinical support staff to produce a detailed screening report within 30 seconds. In areas with limited access to ophthalmologists, a single test can detect multiple eye diseases, reducing vision loss due to these blinding eye diseases.
“Achieving MDR certification is a major milestone for Eyenuk and the result of early adaptation to the more stringent requirements of the new regulations. said Malavika Bhaskaranand, Head of Regulatory and Clinical Affairs at Eyenuk, in a statement.
“This EC certification doubles our impact in two ways. We are now able to help more patients at risk,” Eyenuk CEO and founder Kaushal Solanki said in a statement. We can now provide each patient with a more comprehensive report that includes detections for three diseases, compared to just one.”
Solanki also noted that DR, AMD, and glaucoma are all asymptomatic in the early stages.
“The high sensitivity of the EyeArt AI system and its ability to be delivered without the need for an expert will make it easier to detect the disease early and take preventative measures to protect the vision of these patients,” Solanki said in a statement. said in “We look forward to forging new partnerships with world-class hospitals and medical institutions across Europe to help preserve the sight of millions of people suffering from these diseases across the continent.”
According to the company, its AI system provides autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD) and glaucomatous optic nerve damage, and retinal imaging based on international clinical standards. and provide immediate reporting in a single office visit. During a routine examination of a patient.
Once the patient’s fundus image is captured and sent to the EyeArt AI system, the detection results are available in a PDF report within 30 seconds.
The AI system was developed with funding from the US National Institutes of Health and is being validated by the UK’s National Health Service. This system is reimbursable by U.S. government and private payers under Category 1 Current Procedural Terms (CPT) Code 92229.