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Greg Webb

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

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…

Greg Webb

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

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…

Greg Webb

Public Citizen Chides FDA for Failing to Recall Stryker Stent

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…

Greg Webb

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

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…

Paul Thomson

Studies on FDA lead to changes in testing standards

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…

Greg Webb

Controversial Medical Device – Menaflex – Approved By FDA

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…

Greg Webb

Hospitals In VA, MD, DC Must Report Avoidable Mistakes

Over the past year, there have been hundreds of incidents of death or serious medical harm that were disclosed by hospitals in the Washington DC area, preventable errors that until recently have not…

Greg Webb

Vermont Law Makes Payments to Doctors Public

In an attempt to crack down on the medical industry’s payment to physicians, Vermont legislators have passed a law that requires drug and device manufacturers to publicly release the amount of…

Greg Webb

Congressmen Push To Nullify Supreme Court’s Medical Device Decision

Some members of Congress are attempting to remove a 2008 Supreme Court decision that stands as a barrier against suing medical device manufacturers. This ruling has barred patients, or their…

Greg Webb

FDA May Not Have Adequately Tested Heart Devices for Short-Circuiting, Physician Says

The Food and Drug Administration is about to approve the use of a new electrical component for heart device implants, but it may not have adequately tested the device for potential risks, said Dr….