Recently Approved Devices

The FDA has recently approved the following devices to be marketed. Hydrus® Microstent - P170034 The Hydrus® Microstent is an implantable, flexible, metal (nitinol) tube with windows (open-back stent) pre-loaded onto a hand-held delivery system. The Hydrus® Microstent is intended to reduce eye pressure (intraocular pressure, or IOP) in adult patients with mild to moderate primary open angle glaucoma (POAG) by acting as a support structure in one part of the natural drainage pathway of the eye (Schlemm's canal). POAG is a type of glaucoma where there is no other associated eye disease causing increased eye pressure and where the eye pressure usually rises slowly. This gradual increase in eye pressure can be associated with damage to the optic nerve. PD-L1 IHC 22C3 pharmDx - P150013/S011 PD-L1 IHC 22C3 pharmDx is a laboratory test doctors can use to identify the protein programmed cell death ligand 1 (PD-L1) in tumor tissue obtained from patients who have urothelail cancer. This approval expands the indications for use for this test for determining whether patients with urothelail cancer are eligible for treatment with the medicine KEYTRUDA® (pembrolizumab). Abbott RealTime IDH1 - P170041 The Abbott RealTime IDH1 is a laboratory test intended to detect the presence of five (5) specific mutations in the isocitrate dehydrogenase-1 (IDH1) gene in blood or bone marrow from patients with acute myeloid leukemiadisclaimer icon (AML). If the test result is positive for an IDH1 mutation, the patient may be able to achieve remission and require fewer blood transfusions when treated with Tibsovo (ivosidenib), a drug that targets the mutant IDH1 protein