This article has been updated with comments from the FDA. A recent JAMA Internal Medicine editorial takes another swipe at the FDA for delays in improving its medical device adverse-event reporting. Journal editor Dr. Rita Redberg and Dr. James Salazar, both of Department of Medicine, University of California, San Francisco, note several instances in which […]
JAMA Internal Medicine
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA
Netflix has unleashed a blistering indictment of the medical device industry, the FDA and doctors who accept money from medtech in its new documentary, ‘The Bleeding Edge,’ released today. The film depicts people who have suffered injuries and/or illnesses following placement of Bayer’s Essure sterilization device, Johnson & Johnson’s vaginal mesh, various manufacturers’ metal artificial […]
Study: Medical device trials still ignoring gender, age, race
Despite FDA guidelines, very few medical device trials are analyzed to consider how a user’s sex, age or race could affect safety and effectiveness of the device, according to a new study out of Yale and the University of California-San Francisco. Results from the study were published in Jama Internal Medicine. The study aimed to […]
Study: U.S. patients subject to higher radiation during MPI heart test
Americans undergoing myocardial perfusion imaging to diagnose coronary artery disease, a leading killer in the U.S., are receiving higher levels of radiation than their peers around the world, according to a new study. The study was published in JAMA Internal Medicine this month. The MPI test, performed on millions of U.S. patients every year, is […]
Study: Uncommon form of heart attack likely runs in family
(Reuters) — Although oncologists increasingly distinguish breast, lung, and other cancers by their molecular drivers, cardiologists have lagged behind in efforts to do something similar for heart disease.
