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