Medical Device News (FDA)
EU Looks to Tighten Medical Device Safety With Implant Registry
April 30, 2012 | No comments
In the wake of high-level scandals in the EU, including the Poly Implant Prothese (PIP) breast implant snafu and the metal-on-metal hip …
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FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products
April 26, 2012 | No comments
The FDA’s Global Engagement Report shed light on the volume of imported food, medical devices, and pharmaceuticals and outlines the measures taken …
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Report: Internal FDA Reports Slams European Regulation of Medical Devices as Ineffective
April 24, 2012 | 2 comments
The FDA has criticized Europe’s review process for medical devices in an unreleased internal report, claiming the failure of some …
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Senators Seek to Improve Safety of Children’s Medications and Medical Devices
April 18, 2012 | No comments
A bipartisan team of Senators announced today new legislation aimed at improving the safety of children’s medications and medical devices. The bill introduced today …
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SEC Charges Medical Device Company Biomet with Foreign Bribery
April 3, 2012 | No comments
The Securities and Exchange Commission announced today that it charged Warsaw, Indiana based medical device company Biomet Inc. with violating the Foreign …
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New FDA Guidance on Considerations Used in Device Approval, De Novo Decisions
March 28, 2012 | No comments
The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of …
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Choking Hazard and Serious Injuries with the Spinbrush line of Powered Toothbrushes
March 21, 2012 | No comments
The FDA updated the Agency’s safety notice on a popular line of Spinbrush toothbrushes. The FDA said it was aware of …
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Medside Interview – Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US?
March 18, 2012 | No comments
Should Medical Device Companies Pursue Regulatory Approvals in Europe Before the US? [ 43:02 ] Play Now | Play in Popup | Download (47)If you are interested in learning more about whether to pursure FDA or EU pre-market approval first, take a moment …
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Acclarent Inspira AIR Balloon Dilation System Recalled
March 13, 2012 | No comments
The FDA issued a recall for the Acclarent Inspira AIR baloon dilation system due to the products failure to function …
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FDA reaches $1 million Settlement with Pennsylvania Medical Device Firm
February 29, 2012 | No comments
The FDA Announced today that it reached a settlement with Globus Medical Inc. for the distribution of unapproved medical devices. The FDA and Globus …
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