Final yr, Eyenuk CEO Kaushal Solanki instructed MedCity Information his firm is on a mission to “display each eye on the planet” by leveraging its AI-powered illness detection applied sciences.
Eyenuk nonetheless has loads of work to do to succeed in that aim, however the Los Angeles-based firm did not too long ago attain a major milestone. It obtained FDA clearance to make use of the Topcon NW400 retinal digicam with its EyeArt AI system, which mechanically detects diabetic retinopathy. This FDA clearance provides to the EyeArt AI system’s already-cleared utilization with Canon CR-2 AF and Canon CR-2 Plus AF cameras — Eyenuk mentioned this makes its system the one AI system that’s FDA-cleared to be used with a number of retinal cameras produced by totally different producers.
Eyenuk’s EyeArt system gives screenings for diabetic retinopathy, which happens when the retina’s blood vessels are broken on account of diabetes. The screenings embody retinal imaging, diabetic retinopathy grading on worldwide requirements and fast reporting. As soon as a affected person’s pictures have been captured and submitted to the system, the outcomes turn out to be out there in a PDF report in 10 seconds, based on Solanki.
Age-related eye ailments and continual illness problems like diabetic retinopathy or diabetic macular edema are the main causes of blindness and low imaginative and prescient. These ailments are treatable if recognized early, however suppliers “haven’t been very efficient” in diagnosing and treating these circumstances, Solanki defined. Eyenuk is searching for to deal with this challenge by shifting the paradigm from heavy reliance on specialists to widespread use of autonomous AI screening applied sciences.
The corporate’s system is a prescription software program gadget cleared by the FDA to be operated by anybody who has a high-school diploma. With the latest FDA clearance earned by Eyenuk, the EyeArt system can now be used with three totally different retinal cameras — two made by Canon and one by Topcon.
Solanki mentioned the truth that Eyenuk’s AI system can be utilized with a number of retinal cameras made by totally different producers helps the corporate set itself aside from the competitors — comparable to Digital Diagnostics, which additionally has an AI gadget that was cleared by the FDA to detect diabetic retinopathy.
“By increasing the label to incorporate a number of digicam fashions, we develop the alternatives that suppliers and sufferers have. That may go a good distance in serving to to attain our mission of eliminating preventable blindness via screening,” he mentioned in a latest interview.
Eyenuk sells its expertise to well being plans and a variety of suppliers, together with hospitals, main care clinics, diabetes and endocrinology clinics, eyecare practices, neighborhood well being facilities and federally certified well being facilities. A few of its clients embody Windfall, UnityPoint Well being, Temple College Well being and MaineHealth.
Thus far, the EyeArt system has been used for screening in additional than 230,000 sufferers with diabetes. Now that the EyeArt system is suitable with one other digicam mannequin, Solanki hopes this quantity will improve considerably. Adopting the system will now turn out to be a extra enticing possibility for suppliers who have already got Topcon NW400 cameras, he identified.
“If we need to display each eye on the planet or display everybody with diabetes, we must be suitable with an increasing number of gadgets — that’s how we now have taken a giant step,” Solanki declared.
This newest FDA clearance for Eyenuk’s EyeArt system relies on information from a multi-center scientific trial. The information confirmed that Topcon NW400 cameras achieved 94.4% sensitivity and 91.1% specificity for greater than delicate diabetic retinopathy detection, in addition to 96.8% sensitivity and 91.6% specificity for vision-threatening diabetic retinopathy detection.
Picture: Flickr person Rakesh Rocky
