The AI system expands the supply of vision-saving eye screenings by making automated AI prognosis and coordination of care doable in main care medical practices with out the necessity for a specialist’s evaluation.
Eyenuk has been authorized to market its AI eye screening system (EyeArt) within the European Union for the brand new makes use of of detecting age-related macular degeneration (AMD) and glaucomatous optic nerve injury (glaucoma).
The AI system (model 3.0) has been granted a brand new European Fee (EC) certification as a Class IIb medical system below the EU’s Medical Gadgets Regulation 2017/745 (“MDR”) and is meant to detect indicators of diabetic retinopathy (DR) (together with diabetic macular edema), AMD, and glaucoma in sufferers susceptible to imaginative and prescient loss utilizing computerised evaluation of pictures of the retina. The system was beforehand authorized within the EU for detection of DR.
In response to the corporate, this EC Certification makes the corporate’s AI system the primary and solely autonomous AI answer with Class IIb MDR CE marking for the automated detection of all three eye illnesses and can permit Eyenuk prospects within the EU to detect the illnesses in a single examination utilizing the identical set of retinal pictures.
The corporate additionally famous that its AI system is presently solely system that’s each CE Marked for the detection of the three illnesses in addition to FDA-cleared for the detection of DR, the main explanation for blindness amongst working-age adults.
The AI system expands the supply of vision-saving eye screenings by making automated AI prognosis and coordination of care doable in main care medical practices with out the necessity for a specialist’s evaluation. The system is built-in with retinal imaging cameras and might be operated by medical help employees to generate an in depth screening report in lower than 30 seconds. In areas with restricted entry to ophthalmologists, its means to detect a number of eye illnesses with a single examination can assist scale back imaginative and prescient loss from these blinding eye illnesses.
“Attaining MDR certification is a significant milestone for Eyenuk and a results of our early adaptation to the extra stringent necessities of the brand new regulation. It reaffirms the sturdy outcomes from rigorous medical validation of the EyeArt AI system,” Malavika Bhaskaranand, head of Regulatory and Scientific Affairs at Eyenuk, mentioned in a press release.
“This EC certification multiplies our influence in two methods. First, our autonomous AI can now assist many extra sufferers susceptible to imaginative and prescient loss – the inhabitants susceptible to AMD and glaucoma, notably seniors, along with individuals with diabetes,” Kaushal Solanki, CEO and founding father of Eyenuk, mentioned in a press release. “Second, our AI can now present a extra complete report for every affected person with detection outcomes for 3 illnesses in comparison with only one beforehand.”
Solanki additionally identified that DR, AMD, and glaucoma are all asymptomatic of their early levels.
“The excessive sensitivity of the EyeArt AI system, and its means to be delivered with out a specialist, makes it simpler to catch the illnesses early and to take preventative measures to guard the imaginative and prescient of those sufferers,” Solanki mentioned within the assertion. “We sit up for the chance to forge new partnerships with world-class hospitals and healthcare establishments in Europe to assist protect the eyesight of thousands and thousands throughout the continent with these illnesses.”
In response to the corporate, its AI system supplies autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD) and glaucomatous optic nerve injury, together with retinal imaging, based mostly on worldwide medical requirements and speedy reporting, in a single workplace go to throughout a affected person’s common examination.
As soon as the affected person’s fundus pictures have been captured and submitted to the EyeArt AI System, the detection outcomes can be found in a PDF report in lower than 30 seconds.
The AI system was developed with funding from the U.S. Nationwide Institutes of Well being and is validated by the U.Okay. Nationwide Well being Service. The system is reimbursable by authorities and personal payors within the U.S. below the Class 1 Present Procedural Terminology (CPT) code 92229.
