Regulatory/Legal
Apr 22, 2015
Medical device companies need a superior product and patent protection for their medical devices and related methods of use, but also need to consider a few...
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...
Mar 26, 2015
Manufacturers must realize that the new FDA medical device database makes data its own product. Rajesh Misra and William Poetker FDA rules require medical...
Mar 23, 2015
It is time for FDA to fulfill its primary mission of protecting public health and put patients first. Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD Over...
Jan 28, 2015
The repeal of the 2.3% medical device tax seems more possible now than in the preceding two years because of a Republican Congress and strong bipartisan...