Ensuring patient safety is one of the most vital and challenging roles in health care.

Speed up approval for new health care products and

Sure, the Italians have better food, the English richer royal culture and accents, and French women don’t get fat, but we in America regulate medical devices better, don’t we? Not so fast, says the European Union.

During the next few months, manufacturers of certain in vitro diagnostic and radiology products may start to notice they are getting decisions on their premarket notification submissions, aka

As the Supreme Court debates the fate of “Obama Care,” we should recall the formal name of the law: the Patient Protection and Affordable Care Act (PPACA).

While calling it one of the more “egregious” examples he’s seen or heard about, Fisher Wallace Labs (FWL) CEO Chip Fisher said the Food and Drug Administration’s (FDA) attempt to “force its own agenda” over d

Banner Medical is committed to an ambitious approach to quality assurance, one developed specifically for the evolving, critical needs of the medical device industry.

Predicting things on Capitol Hill is never easy, especially as the election campaign “silly season” enters the picture, but it’s beginning to look like medical device companies should ex

In my March 7, 2012, column, “An Elegantly Simple but Counterintuitive Approach to Analysi

Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the