U.S. advisers call for new medical device regime

WASHINGTON (Reuters) - An advisory group said the U.S. fast-track approval process for medical devices is fatally flawed and should be replaced, but the Food and Drug Administration said the recommendation was a non-starter.

The FDA had asked for the Institute of Medicine report as start of a broad agency review of its device unit, an area dogged by high staff turnover, funding woes and major recalls in recent year of devices ranging from artificial hips to heart defibrillators.

Bullshittery in the David K Case

David K has a public apology on his blog. For some reason, some people have characterized it as a release for David K.

These masses are almost as isolated from reality as a Palin family reunion!

David K's apology doesn't present a loss. It really represents a win. Anyone who knows their ass from a hollow in the earth knows that it was likely because of a settlement. It could've been much worse.