With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation - and in the healthcare sector no less - the FDA user fee reauthorization act. Last week, the U.S. House of Representatives reaffirmed passage of the FDA user fee reauthorization act in a 387-5 roll call vote taken after an earlier voice vote. The House affirmation followed close on the heels of the earlier congenial vote on the act by the Senate, a nearly unanimous 96-1 approval. The groundwork...

In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it appears that this once proud and successful domestic industry is on life support. Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer...

Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges for the industry, but also many rewards for those willing to follow promising trends. 1. Healthcare Information Technology is going to be big this year and probably into the foreseeable future. This is the final year in which hospitals and physicians can demonstrate meaningful use and get maximum healthcare dollars under the stimulus, so there should probably be some clarification...

SAN FRANCISCO —− Attendees who stuck around until the end of Wednesday were blessed with a real treat, a chance to pick the brain of the head of the Center for Devices and Regulatory Health (CDRH), Jeff Shuren, MD. While there was no actual cannibalism involved, entrepreneurs certainly hungered to hear some good news from someone so closely involved with regulatory policy from Washington. (Medical Device Daily)

SAN FRANCISCO The large healthcare systems are an extremely important customer for companies involved in the healthcare sector, and if these companies aren't thinking about how to keep these deep-pocketed customers happy, they do so at their own peril.

SAN FRANCISCO Just a couple of blocks away from the shoulder-to-shoulder crowds at the J.P. Morgan Healthcare Conference, the much smaller OneMedForum conference on healthcare was moving along at the Sir Francis Drake Hotel. A Tuesday morning track on diagnostics held attendees in thrall, with several intriguing private companies vying for the affections, and potentially, funding from investors. (Medical Device Daily)

SAN FRANCISCO − Early arrivals to this year's addition of the J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel were treated to something that would soon be in short supply . . . elbow room. This reporter was certainly envious when Managing Director Kevin Willsey noted that the first meeting back in 1983 had less than 100 attendees. This year's addition of what is arguably the preeminent conference in the healthcare sector had more than 8,500 registered attendees. (Medical Device Daily)

By JIM STOMMEN, Medical Device Daily Contributing Writer  The arguments going on these days over the prostate cancer screening test known as prostate-specific antigen (PSA for short) might make one think that there’s something wrong with the test itself. Not so. The argument by what we will refer to as the “anti” side of the issue is with what happens after the routine blood test comes back with a positive finding. Those folks, who go by the name U.S. Preventive Services Task Force, maintain that the PSA test leads to demonstrative levels of over-treatment, doing so to such an extent...

I went to see my doctor a few weeks ago for a physical. Since I just turned 40, he recommended that I have a CT scan to check for calcification in my heart valves. Maybe I would have said  "no," when he mentioned that the cost would not be covered by insurance, but his cautionary tale about a person he knew who had collapsed and died of a heart attack at the age of 42 persuaded me that maybe this was a good idea after all. I went in for the test yesterday and the entire procedure took less than...