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...

Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let's take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less than the average time needed to get a patent through the U.S. Patent and Trademark Office, which is another story. Aug. 12, 2009: Schultz out at CDRH; Shuren to serve as interim director On Aug. 11, 2009, the Internet was abuzz with reports that Dan Schultz, MD, had stepped...

My little West Central Illinois town got hit with a thunderstorm a couple nights ago. Even though my 3-year-old son handles storms exceptionally well for his age, I decided around 2 a.m. I needed to peek in his room to make sure he was okay. To my surprise, I found him lying in bed awake. I asked if the storm was keeping him awake. “No. I’m sick,” he said. Sure enough, a quick touch of his forehead and cheeks told me he had a fever – and probably a rather high one at that. But to determine how bad it...

Much to my annoyance, I’ve often been mistaken for being younger than my actual age. At 24 I could not buy a lottery ticket without being carded (even though 18 is the legal age for that in my state). A few years ago a 14-year-old neighbor girl spotted me in the front yard and asked what school I attended because she thought we were the same age. And just a few months ago my son and I both received a kids’ menu at Perkins when the hostess mistook me for 12 or under. And for as long as I can...

When one thinks about countries that are hotbeds for medical technology innovation, Israel would not likely be at the top of anyone’s list. But people in the know will tell you that this small country, with a population of just a shade over 7.5 million people, has a reputation for being a tireless innovator in the field, with countries from all over the world flocking there to study their business model. According to the Israeli Life Science Industry, an advocacy group, the med-tech industry is also young and growing. Of the currently operating 702 companies, 56% were founded during the...

Is the sky falling? Device makers keep saying so By MARK McCARTY Medical Device Daily Washington Editor FDA's Center for Devices and Radiological Health is certainly on a regulatory tear of late, and industry is understandably rattled by some of the developments. After all, CDRH only recently managed to shed a couple of obvious malcontents in the persons of Robert Smith, MD, and Julian Nichols, MD, who both worked at the Office of Device Evaluation at CDRH and were not exactly happy to get their walking papers. My impression is that you have to be either really obnoxious, noticeably incompetent,...