Eyenuk has received 510(k) clearance from the FDA to market EyeArt, an autonomous AI system for diabetic retinopathy screening, according to a press release.
The system is designed to automatically detect more than mild diabetic retinopathy and vision-threatening diabetic retinopathy in adults with diabetes in one test. The system has diagnostic outputs for each of the patient’s eyes.
The clearance was based on a preregistered, prospective, multicenter pivotal clinical trial of 380 patients at seven primary care sites and 275 patients at four ophthalmology sites. Topline results found 96%
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