Regulatory and Compliance
Apr 22, 2015
Marie Thibault   Here at MD+DI, we love medical devices and advances in healthcare technology. Innovative medical devices have helped us live longer...
Apr 21, 2015
Medical device companies can increase efficiency by tightening up their risk management practices. Jamie Hartford Efficiency is the name of the game for...
Apr 21, 2015
Marie Thibault FDA has set out its current thinking about data from clinical studies conducted outside the United States (OUS) in a draft guidance published...
Apr 20, 2015
Breast Implants In January 2011, FDA issued a report saying it was aware of a potential association between breast implants and anaplastic large cell lymphoma...
Apr 20, 2015
da Vinci Surgical System Robotic surgery seems to be the way of the future—every other industry is becoming automated, so why not surgery? Intuitive...
Apr 20, 2015
Essure Permanent Birth Control The Essure system, now owned by Bayer after it acquired Conceptus in 2013, is intended to provide non-surgical permanent birth...
Apr 20, 2015
Duodenoscopes Though there had been dozens of reported cases at several hospitals before, the issue of contaminated duodenoscopes didn't become a mainstream...
Apr 20, 2015
Power Morcellators In late 2013, media coverage of power morcellators, a tool used during laparoscopic hysterectomies, drew attention to the controversy around...
Apr 20, 2015
Recent media coverage of adverse events related to morcellators and duodenoscopes exposes the incompetence of FDA's Center for Devices and Radiological Health...
Apr 20, 2015
Marie Thibault FDA has put out a call for makers of home-use medical devices to consider participating in a pilot program that would create an online...