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In Brief: Dr. Kremer's PMA

This article was originally published in The Gray Sheet

Executive Summary

Dr. Kremer's PMA: FDA Ophthalmic Devices Panel recommends against approval of a single-site premarket approval application sponsored by Frederic Kremer, MD, for a system to perform laser- assisted in situ keratomileusis. In a 4-2 vote, panel members cite poor patient accountability and inadequate standardization of post-operative patient evaluation. Kremer's PMA for the Laser-K laser-based system included data on 2,500 patients in two study cohorts. Uncorrected visual acuity at one-year follow-up was 92.2% for one group, 87.4% for the other cohort. The panel's rejection of the PMA likely will deal a blow to a licensing agreement between Kremer and Lasersight. Under the deal, Kremer must obtain a PMA approval allowing Lasersight to commercialize a LASIK system by July 28, or else the company can return the technology to Kremer...
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