New Products In Brief
This article was originally published in The Gray Sheet
Recent market launches and clearances include Glaukos’ iStent for glaucoma, Beckman Coulter’s Prostate Health Index blood test for prostate cancer and Siemens’ Sysmex CA-600 Systems for lab hemostasis testing.
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FDA issued a "leap frog" draft guidance for minimally invasive glaucoma surgery (MIGS) devices based on strong interest in the nascent field from manufacturers. The recommendations under the guidance reflect discussion during a 2014 stakeholder workshop.
The final recommendations are a major shift in policy for the commonly performed blood test, and one certain to face ongoing controversy.
Glaukos will likely have to conduct a new, five-year prospective randomized post-market study for its iStent glaucoma device if FDA approves the product's PMA