Medical Devices & Implants

• Does the FDA Know Your Medical Device ID?

  Greg Webb | May 14, 2012 8:00 AM | 0 CommentsCharlottesville, VA

  The Food and Drug Administration (FDA) tracks prescription drugs using a medicine’s unique code. Some devices that are implanted in patients have identification numbers also, such as heart...

• Expert Advice Sought By FDA on Metal-on-Metal Hip Implantation

  Greg Webb | March 30, 2012 11:59 AM | 0 CommentsCharlottesville, VA

  The U.S. Food and Drug Administration is soliciting advice from scientific and medical experts outside the FDA to evaluate recent information on the metal-on-metal hip implant devices in order...

• Bipartisan U.S. Senate Bill Aims to Make Medical Devices Safer

  Greg Webb | March 26, 2012 8:00 AM | 0 CommentsCharlottesville, VA

  Recently, four U.S. Senators from both parties came together to introduce Senate bill 2193, Ensuring Safe Medical Devices for Patients Act, in an effort to strengthen the U.S. Food and Drug...

• Consumer Reports Criticizes FDA Medical Device Approval Process

  Greg Webb | March 16, 2012 8:00 AM | 0 CommentsCharlottesville, VA

  Consumer Reports, the organization behind the magazine famous for its “Best and Worst Cars” annual issue, now is taking issue with the U.S. Food and Drug Administration (FDA) approval...

• Riata Defibrillator Lead Recall by St. Jude Medical Causing a Stir

  Greg Webb | March 07, 2012 8:00 AM | 6 CommentsCharlottesville, VA

  In an article on Mass Device’s newsletter of March 6, 2012, Dr. Robert Hauser is quoted as saying, Patients in the U.S. continue to be exposed to under-performing and potentially...

• Hip Implants Greater Cause for Concern in Europe and the U.S.

  Greg Webb | February 29, 2012 8:00 AM | 0 CommentsCharlottesville, VA

  Metal-on-metal hip devices have risen to the top of the stack of causes for concern, eclipsing other devices, including leaking breast implants, according to the British Medical Journal (BMJ) and...

• Public Citizen Chides FDA for Failing to Recall Stryker Stent

  Greg Webb | January 30, 2012 8:00 AM | 0 CommentsCharlottesville, VA

  According to a recent Bloomberg Businessweek article (Jan. 12) by Michelle Fay Cortez, Michael Carome, deputy director of Public Citizen’s Health Research Group and author of a petition to...

• Metal-on-Metal (MOM) Hip Replacements Cause for Concern

  Greg Webb | May 13, 2011 4:16 PM | 0 CommentsCharlottesville, VA

  In February 2011, the Food and Drug Administration (FDA) issued a public health communication about Metal-on-Metal (MOM) hip replacement components”[1] and the possibility of adverse effects...

• Studies on FDA lead to changes in testing standards

  Paul Thomson | January 07, 2010 9:27 AM | 0 CommentsCharlottesville, VA

  The Food and Drug Administration (FDA) is developing guidelines for higher standards for data when testing medical devices on humans, according to the New York Times. Such standards will include...

• Controversial Medical Device - Menaflex - Approved By FDA

  Greg Webb | October 07, 2009 5:11 PM | 2 CommentsCharlottesville, VA

  In a bid to get a controversial knee-surgery device known as Menaflex approved by the Food and Drug Administration (FDA), ReGen Biologics relied too heavily on two consultants with strong ties to...