Regulatory/Legal
May 08, 2015
CDRH director Jeffrey Shuren tells legislators that FDA should be the regulator of next-generation sequencing tests and pledges to develop ways to provide...
May 06, 2015
A look at what’s new in two recent legislative efforts to define FDA oversight of software. Bradley Merrill Thompson MEDTECH Act The Medical Electronic...
Apr 30, 2015
CDRH claims to be losing talented employees to industry; patient advocates believe this is evidence of a too-close relationship between the center and...
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 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...