www.fdanews.com/articles/183080-optovues-ocular-mapping-software-wins-fda-nod
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Optovue’s Ocular Mapping Software Wins FDA Nod
August 11, 2017
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.