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Fdanewsdevicedailybulletin

Feb. 3, 2012

Vol. 9 No. 24

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U.S., EU Devicemakers Promote Ethical Ties With Distributors

U.S. and European devicemakers should establish compliance programs integrating individual risk analyses with local laws to ensure ethical interactions with third-party distributors, an AdvaMed-Eucomed joint guidance states. Read More

FDA Offers Guidance on Humanitarian Use Device Requests

The U.S. Food and Drug Administration (FDA) is asking for comments on new draft guidance on humanitarian use device (HUD) designations. Read More

China Department of Health Issues Recall for Stent System

The Chinese Department of Health has issued a field safety notice for Cordis’ S.M.A.R.T. Control Nitinol stent system due to a sterility breach in all pouches of the stent system. Read More

France to Control Risky Medical Devices

French Health Minister Xavier Bertrand on Wednesday announced tighter controls over the market for risky medical devices, in the wake of the faulty breast implant scandal. Read More

Ireland to Be Medical Tech Leader

Ireland is being positioned as a global leader of the medical technology sector by 2015, with the industry set to be a “key driver” in the country’s ongoing export-led economic growth. Read More

Emory University Study Reveals Silicone Breast Implant Device Significantly Reduces Contamination

The Aesthetic Surgery Journal published an article by Emory University researchers on an FDA Class 1 device used in the delivery of silicone gel implants. Read More

Idaho Files for FDA Clearance of Expanded FilmArray Respiratory Panel

Idaho Technology has filed for FDA 510(k) clearance of five additional respiratory pathogens for its FilmArray respiratory panel. Read More

Bovie Medical Corporation Receives 510(k) Clearances to Market J-Plasma Device

Bovie Medical announced that the it received 510(k) clearance from the FDA to market its J-Plasma hand piece with retractable cutting feature for soft tissue coagulation during surgery. Read More

Discovery Labs Receives FDA Approval for Medical Device

Discovery Laboratories announced that it has received approval from the Food and Drug Administration to begin marketing a new medical device for respiratory patients. Read More