Genzyme gets US FDA marketing nod for Renvela (PharmaBiz)
Genzyme Corp. announced that the US Food and Drug Administration have granted marketing approval for Renvela (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

ATS Medical Receives FDA Clearance For ATS Simulus Semi-Rigid Annuloplasty Ring (Medical News Today)
ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced U.S. Food and Drug Administration (FDA) clearance for the ATS Simulus(R) Semi-Rigid Annuloplasty Ring. [click link for full article]

FDA, med-test makers tangle over approvals (BizJournals)
Sin Hang Lee isn't afraid. The Connecticut pathologist, who spends his spare time developing viral diagnostics, says the U.S. Food and Drug Administration has failed to give him guidance on how one of his tests should be regulated. He mounted a lawsuit against the venerable agency last week.