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.

Cooper recalled millions of the Avaira Toric lenses last year after receiving reports of eye pain and corneal abrasion, later expanding the recall to include lenses from its Avaira Sphere line.

 Delcath Chemosat component wins CE Mark
Delcath (NSDQ:DCTH) said it won CE Mark approval in the European Union for the latest iteration of a component for its Chemosat liver cancer treatment.

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

 Elekta lands CE Mark for beam-shaper
Elekta (STO:EKTA B) won CE Mark approval in the European Union for the Agility, a beam-shaping device integrated into the head of a linear accelerator. 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

 Anulex touts expanded fiXate clearance
Anulex Technologies said it won 510(k) clearance from the FDA for expanded indications for its fiXate tissue band.  Read more

 Fenwal wins 510(k) for plasma exchange protocol

Fenwal said the FDA cleared a therapeutic plasma exchange protocol for its Amicus separator. Read more

 Devon Medical’s NPWT device wins FDA nod

Devon Medical nabbed 510(k) clearance for its extriCARE 2400 negative-pressure wound therapy system. Read more

 Navidea wins Lymphoseek extension
Navidea (NYSE:NAVB) said the FDA gave it a 90-day extension of the Prescription Drug User Fee Act date for its Lymphoseek radioactive tracing agent. Read more

 Estech gets conditional IDE for ATTAC-AF trial
Estech said it won conditional investigational device exemption from the FDA to start patient enrollment in its ATTAC-AF trial. Read more