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Study: Abbott, Edwards may have mislabeled hundreds of patient deaths

October 8, 2019 By Nancy Crotti Leave a Comment

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 […]

Filed Under: Cardiac Implants, Featured, Food & Drug Administration (FDA), Implants, Replacement Heart Valves Tagged With: Abbott, deviceevents, Edwards Lifesciences, FDA, JAMA Internal Medicine

Netflix’s ‘The Bleeding Edge’ blasts medtech & FDA

July 27, 2018 By Nancy Crotti Leave a Comment

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 […]

Filed Under: 510(k), Food & Drug Administration (FDA), Gynecological, Metal-on-Metal, Neurological, Pre-Market Approval (PMA), Regulatory/Compliance Tagged With: AdvaMed, Bayer, British Medical Journal, FDA, Intuitive Surgical, JAMA Internal Medicine, Johnson and Johnson

Study: Medical device trials still ignoring gender, age, race

July 24, 2017 By Fink Densford Leave a Comment

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 […]

Filed Under: Clinical Trials Tagged With: JAMA Internal Medicine

Study: U.S. patients subject to higher radiation during MPI heart test

December 29, 2015 By Fink Densford Leave a Comment

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 […]

Filed Under: Cardiovascular, Clinical Trials Tagged With: JAMA Internal Medicine

Study: Uncommon form of heart attack likely runs in family

March 23, 2015 By MassDevice Leave a Comment

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.

Filed Under: Cardiovascular, News Well Tagged With: Clinical Trials, JAMA Internal Medicine

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