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Medical Devices / Submissions and Approvals

Optovue’s Ocular Mapping Software Wins FDA Nod

Aug. 14, 2017
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The FDA cleared Optovue’s epithelial thickness mapping software.

The software is intended for quantitative measurements of the cornea’s epithelial and stromal layers. The clearance makes the software the first FDA-cleared product to provide such measurements, according to the Fremont, Calif.-based firm.

Clinical trials of the software showed it was capable of identifying issues with the epithelial layer in patients with keratoconus as well as dry eye disease.

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