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BioWorld - Saturday, June 6, 2026
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Home » Eyeyon eyes FDA breakthrough device designation for endothelial implant
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Eyeyon eyes FDA breakthrough device designation for endothelial implant

Feb. 6, 2020
By Stacy Lawrence
The FDA has awarded a breakthrough device designation to a polymer film implant to create an artificial endothelial layer in the eye. Known as Endoart, it is designed to replace a non-functioning endothelium, which is the single layer of cells on the inner surface of the cornea. Without it, excess fluid flows into the cornea and can result in severe vision loss.
Medical technology Regulatory Ophthalmic Middle East North Africa FDA

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