November 27th, 2008 joshua
Bayer AG has agreed to pay $97.5 million to settle a lawsuit that it made illegal kickback payments to physicians so they’d use their brand of diabetic equipment.
The Food and Drug Administration, as well as a few other regulators, have begun investigating the millions of dollars medical device makers have been paying physicians. For years, […]
November 26th, 2008 laurie
Older ventricular assist devices (VADs) — tiny pumps implanted in people with failing hearts — are costly but provide limited benefits, a study published in the Journal of the American Medical Association finds.
HealthDay News reports that the study used data on almost 3,000 people who had VADs installed in a Medicare program between 2000 […]
November 24th, 2008 laurie
The FDA has announced another insulin pump recall, this time by Animas for defective battery caps. Battery caps used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump are subject to a Class 1 recall.
Class 1 recalls are the most serious type of recall and […]
November 20th, 2008 joshua
The House Energy and Commerce Committee is investigating a series of bullying from management at the Food and Drug Administration, pushing dangerous medical devices to market despite damning evidence.
FDA scientists - both current and former - revealed in a letter that they’ve been or were consistently badgered to alter findings on dangerous medical devices and […]
November 19th, 2008 laurie
Dow Jones reports that Medtronic has received a subpoena from the U.S. Department of Justice regarding usage of its Infuse Bone Graft product in a manner not approved by the U.S. Food and Drug Administration, the company’s top official said Tuesday.
The product is specifically approved for use in the lower back but has commonly […]
November 18th, 2008 laurie
New York health commissioners’ proposed ban on manufacturing multi-dose vials has been rejected by the FDA.
At the beginning of the year New York City’s health commissioner, Dr. Thomas Frieden, and state Health Commissioner Dr. Richard Daines, sent a letter to the head of the FDA, Andrew von Eschenbach, asking for the ban on manufacturing […]
November 12th, 2008 joshua
More and more research indicates hip resurfacing surgery, used an alternative to total hip replacement for middle-aged women, often leads to more failures and the need for a follow-up surgery.
Hip resurfacing surgery aims to preserve more of the femoral bone than the traditional total hip replacement.
Resurfacing has been used in Europe and Australia longer than […]
November 10th, 2008 joshua
A cardiologist at Beth Israel Deaconess Medical Center told the American Heart Association conference on Sunday that headphones and earbuds (popular with MP3 players and iPods) can alter the performance of implanted heart devices.
These devices include implanted defibrillators as well as pacemakers and can fail to operate if headphones are kept too close to the […]
November 6th, 2008 joshua
The Food and Drug Administration recently announced it is notifying health care professionals and patients that Tyco Healthcare Group is recalling one lot of ReliOn insulin syringes due to a possible mislabeling.
The syringes are the sterile, single-use, disposable, hypodermic syringes with permanently affixed needles. The label error could lead to patients to administer a dose […]
November 6th, 2008 laurie
Medtronic has released updated figures on its defective Sprint Fidelis defibrillator leads, recalled in October of last year for fracturing/malfunctioning and killing several people, injuring hundreds of others.
WebMD reports Medtronic yesterday released updated data showing that the leads, have had 42-month failure rates of 6.3% based on SLS figures and 3.8% according to the CareLink […]
