News tagged with 'medical Devices'

A nonprofit representing 32 medical societies has released a new code of ethics that stresses disclosure of financial conflicts from drug and device makers by doctors and medical journalists.

Two years after the Riegel decision by the U.S. Supreme Court, patients injured by medical devices still have no recourse in the court to hold the device maker accountable. The Riegel decision applies to medical devices that undergo FDA approval, many do not.

Medtronic, with a history of defective heart products, has had a catheter-placed heart valve approved by the FDA on humanitarian grounds because it will be used by fewer than 4,000 patients annually.

The FDA issues a recall notice for the ev3 catheter, but the company says it has collected all defective medical devices. Meanwhile, consumers injured or their survivors still cannot pursue litigation under the existing U.S. Supreme Court Riegel decision.

Stryker Biotech LLC and its executives were indicted by a grand jury Wednesday, accused of fraudulently marketing its bone-growth products and covering-up the misconduct. They face prison time and fines.

A review of the process that fast-tracks medical devices into the marketplace without a safety review will be undertaken by the Institute of Medicine. The review will take two years, long overdue say patients hurt by devices that have been fast-tracked.

Universities are often not told about the money their academics receive from device makers as consultants and product developers.

The results of a new study suggests implantable cardioverter defibrillators (ICDs) are not effective in women.

J & J won preliminary approval to market a new ceramic-on-metal hip replacement device that is thought to be an improvement over metal-on-metal.

Two major shakeups at the Food and Drug Administration may be signs of how the agency is remaking itself to become more pro-consumer and less friendly to the industries it tries to regulate.

Kristen Diane Parker, a former Colorado surgery technician accused of stealing syringes filled with pain medication and switching them with used syringes, despite knowing she had hepatitis C, has been denied bail. Parker's actions put nearly 6,000 patients at risk.

A former surgeon at Walter Reed Army Medical Center made false claims about the Infuse bone-growth product sold by Medtronic Inc., a U.S. medical device maker.

A lawsuit filed by Robert Bozicev against Schering-Plough, alleges that the blood clot that led to the death of his wife, Jackie, in December 2007 was caused by her birth control device, NuvaRing.

President Obama will have an opportunity to shape future decisions from the highest court in the land.  Supreme Court Justice David Souter is retiring in June. Souter is one of the more liberal leaning justices and sided with the majority in the case of Diana Levine v. Wyeth and with the majority in the case of Riegel v. Medtronic, both tests of federal preemption.

About 13 million American women experience stress urinary incontinence and the Ethicon TVT vaginal mesh is the gold standard for treatment. While the company reports an 84 to 95 percent success rate, doctors who deal with mesh complications say the number of problems appear to be vastly underreported and a national registry is needed now.