Regulatory/Legal
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...
Oct 13, 2014
By David P. Mierswa    The healthcare Industry is facing many legal issues that not only affect healthcare workers, but patients as well. “...
Jun 09, 2014
By Scott Sheaf     This is a pretty exciting time for mHealth and personalized medicine. We are on the brink of major changes in the way we manage...
May 29, 2014
By Keith Barritt   Should you submit your app for FDA clearance? Keith Barritt of Fish and Richardson, a law firm specializing in medical device...
Mar 21, 2014
  In a letter to FDA commissioner Margaret Hamburg, a bipartisan group of senators asks what impact congressional legislation might have on FDA...
Mar 05, 2014
By Reade Harpham     Mobile device owners have developed an insatiable appetite for mHealth-related applications. According to industry estimates,...
Mar 03, 2014
Today's orthopedic practitioner and their technology-driven assets are a far cry from the bone saw wielding image of 100 years ago. Today's implant surgeons...