As I read through one particular healthcare-related news item recently, the lyrics to the old “If you’re happy and you know it” song just plain took over my subconscious thinking. You know the one I’m talking about: “If you’re happy and you know it, then your face will surely show it.” It may not come as any great surprise that smiles aren’t adorning the faces of too many doctors these days, what with Medicare payment cuts, the looming impact of healthcare reform, skyrocketing malpractice premiums and other lesser complaints and concerns. But all that notwithstanding, it was just short of...

Reading last weekend’s Wall Street Journal review of “The Forever Fix: Gene Therapy and the Boy Who Saved It” I was struck by an anecdote. It’s about an interview the reviewer did with a scientist who works in the field of neuroprostheses, and that scientist’s refusal to talk about the possible practical applications of his work, because, he said, “false hope is a sinful thing.” Really? To me, it seems like an inevitable part of hope is that it might be false. To illustrate, I don’t hope that my neighbors will be nice to me, because it’s a sure thing....

By JIM STOMMEN Medical Device Daily Contributing Writer The recent decision by the Obama administration to propose big-time funding cuts for medical prevention and wellness programs is, like many of the decisions that come out of Washington, puzzling to say the least. Done as part of the extension of the payroll tax cut, the prevention/wellness cuts supposedly are the political quid pro quo for the lawmakers agreeing to maintain Medicare payments to physicians at existing levels for the remainder of this year — the so-called “Doc fix.” With a snip-snip here and a snip-snip there, seemingly worthwhile wellness efforts such...

The story has been out for a while about transcatheter aortic valve replacement (TAVR), so maybe it's time to project into the future. Before we head there, however, we should revisit the past. The pivotal event in this story is the drug-eluting stent, a device that gave birth to what FDA's Bram Zuckerman, MD, described as the DES trauma. The DES story is twofold; rapid physician adoption and late-stent thrombosis (LST). FDA saw the rate of adoption as an unruly and harmful stampede because of LST, but...

There are many definitions for the word “crazy,” and here's another. Crazy is when you want to get out of Medicare and save the government and the taxpayer money, but the government won't let you. Recent reports indicate that a group of five senior citizens, including former Texas Republican congressman Dick Armey, are okay with their Social Security benefits, but that the law is forcing them to enroll in Medicare Part A if they want to stay on Social Security. The case made it to the Court of Appeals for the District...

By JIM STOMMEN Medical Device Daily Contributing Writer   Talk about eating from the public trough: The folks who run Medicare are putting their money where our collective mouths are. The nation’s largest health insurance plan reported awhile back that it will pay for screenings and preventive services aimed at helping recipients battle obesity and its attendant medical ailments. For those who screen positive for obesity, the newly covered benefits include initial weekly counseling for the first month, followed by five months of every-other-week appointments. Presuming weight loss continues, another six months of once-monthly sessions may follow. My initial response...

By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical's Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...

MONTREAL ‑ At this week’s American Society for Human Genetics annual meeting, where there is a whole genome sequence there is somebody bringing up privacy concerns. Do you really want your genome data to be laid bare? Will it start in a research database, move to your doctor’s office, and soon enough be found floating around on the Internet? Most of those privacy concerns focus on medical issues, which makes a lot of sense. Certainly, most people would not feel warm and fuzzy about having their insurance companies know that, like Craig Venter, they have a higher-than-average risk of developing...

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...