Infinitech's Perfluoron cleared:
This article was originally published in Clinica
Executive Summary
Infinitech's perfluorocarbon liquid, Perfluoron, has received US FDA approval less than one year after the St Louis-based company filed for pre-market approval. Perfluoron was granted expedited review status by the FDA and the agency's Ophthalmic Devices Panel recommended approval late last year. The liquid offers an alternative to silicone oil or gases for injecting into the eye during retinal reattachment surgery to flatten the damaged retinal membrane. The company estimates a $15-20 million US market annually for its product, with a similar international market.