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Devon Medical Products

Devon Medical gains extriCARE CE Mark

May 17, 2013 By Ingrid Mezo Leave a Comment

YYmeta

Devon Medical today launched its portable extriCARE 2400 Negative Pressure Wound Therapy system at the European Wound Management Association conference is Copenhagen, Denmark, after it won CE Mark approval in the European Union.

"The extriCARE system has proven itself in the U.S. as a powerful device that healthcare professionals can rely on for the management of non-healing wounds, including diabetic ulcers and chronic, acute, traumatic, subacute, and dehisced wounds," Devon Medical founder and CEO Dr. John Bennett said in a press statement.

Filed Under: News Well Tagged With: Devon Medical Products, Negative-Pressure Wound Therapy

FDA lets Cooper’s Avaira Toric back on the market | Regulatory Roundup

April 6, 2012 By MassDevice staff Leave a Comment

Avaira

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Anulex Technologies Inc., CE Mark, Delcath Systems Inc., Devon Medical Products, Elekta, Estech, Fenwal Inc., Investigational Device Exemption (IDE), Navidea Biopharmaceuticals, Steris Corp., The Cooper Cos.

Philips lands 510(k) for HeartNavigator valve replacement | Regulatory Roundup

December 22, 2011 By MassDevice staff Leave a Comment

Updated Dec. 23, 2011, to correct that the HeartNavigator is inserted through a small incision in the leg, not in the chest.

HeartNavigatorPhilips’ HeartNavigator aortic valve replacement system uses x-ray imaging to guide the valve to the heart.

Philips Healthcare (NYSE:PHG) landed FDA clearance for its HeartNavigator heart valve replacement system.

Medical City Dallas Hospital became the first U.S. hospital to use the system, which was launched in Europe in the first quarter of this year.

Filed Under: Food & Drug Administration (FDA), News Well, Replacement Heart Valves Tagged With: Devon Medical Products, OptiMedica Corp., Philips, TriReme Medical Inc., uptakemedical

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