Cooper Cos. (NYSE:COO) today announced that the U.S. Food and Drug Administration has granted a Special 510(k) clearance for CooperVision’s Avaira Toric two-week silicone hydrogel contact lenses for astigmatism.
CooperVision will re-launch Avaira Toric with shipments available for select distribution beginning in early May 2012.
The New York-based company’s device isolates the liver so that chemotherapy drugs can be delivered to the organ without exposing other, healthy tissue. The new component is a hemofiltration cartridge.
President & CEO Eamonn Hobbs said the first procedure using the new cartridge is slated for next week. Read more
Steris product gets new device category, 510(k) from the FDA
Steris (NYSE:STE) said the FDA cleared its Verify spore test strip via a de novo determination, making it the first product cleared for a new category of device for use with liquid chemical sterilants. Read more