medical device Tagged Articles
FDA warns against long-term use of IVC filters
The Food and Drug Administration (FDA) is alerting emergency medicine and surgery professionals of serious adverse events that may result from the long-term use of inferior vena cava (IVC) filters. IVC filters are a type of catheter that is implanted
Man says faulty defibrillator felt like being kicked by horse
“It felt like having a horse inside you trying to kick its way out of your chest,” says Bill Storms of Delaware, Ohio, describing what it felt like when the Medtronic cardiac defibrillator implanted in his chest began malfunctioning and
Medtronic informs doctors of faulty pacemakers; Letter to patients to follow
Medical device maker Medtronic sent a letter to doctors worldwide earlier this month warning that nearly 37,000 of its Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002, could have faulty wiring that can cause the pacemakers
Hamburg hopes to create a culture in FDA where concerns are heard
President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices
Alabama man injured by cardiac defibrillator sues manufacturer
Beasley Allen Law Firm attorneys P. Leigh O’Dell and Ted G. Meadows filed a lawsuit on April 29, 2009, on behalf of Patrick M. Lancaster of Alabama, alleging that the plaintiff suffered injuries as a result of having been implanted
FDA meeting could compromise Medical Device Safety Act
The Food and Drug Administration (FDA) has planned an internal meeting today to discuss the strategic direction of the agency’s medical device center, adding fuel to concerns that the government agency carelessly approved medical devices and as a result put
FDA to crack down on medical device manufacturers
The Food and Drug Administration (FDA) is cracking down on makers of medical devices that fall in the most risky category of products approved by the FDA, ordering the companies to provide tougher evidence of their products’ safety and effectiveness
