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The company’s flagship product, AEYE‑DS, has received FDA clearance as the first fully autonomous AI solution for diagnosing referable diabetic retinopathy using either desktop or portable handheld retinal cameras. Clinical trials demonstrated sensitivity of up to 93% and specificity up to 94%, with >99% imageability using only one image per eye and rarely requiring dilation. The system enables point-of-care diagnosis in under one minute. A follow-on pipeline program aims at autonomous glaucoma detection.
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