The general public might think of FDA and CMS as ingredients in the government’s alphabet soup, but there are times when things seem to move too slowly for a mere broth to be the medium. Here are two stories that are taking a lot of time to achieve the required viscosity. First, let’s tackle some of the blowback attached to FDA’s latest attempt to finesse the First Amendment on the point of off-label use. Off-label device use has been the bane of FDA for years, and...

Change is what the American public was promised (or some might say threatened with) during the 2008 presidential election and for better or worse, the healthcare industry worldwide has been served an extra large helping of that change over the past six years. While the medical device industry’s palate has reacted to most of that change the way a five-year-old reacts to Brussels sprouts, this year’s menu does appear to be more appetizing. In March, two competing companies filed IPO papers on the same day. TriVascular Technologies and Lombard Medical Technologies both sell devices to treat abdominal aortic aneurysms. TriVascular...

The 2014 scientific sessions hosted by the Heart Rhythm Society are over, and there was a lot of news coming out of San Francisco. One of the items that caught my eye was a consensus statement by HRS and a couple of other physician societies about appropriate use of implantable cardioverter defibrillators for populations not well represented in clinical trials. The first question that occurs to the casual observer is; how seriously will government take this consensus standard? The background for this is in part the...

The Medical Device Daily Perspectives blog is finally back, and we’d like to thank everyone on the IT team at ThomsonReuters for restoring the blog. I’ve always had the feeling that anyone in the IT business probably feels like salt-water taffy at a toddler’s birthday party: They’re constantly getting pulled in a dozen different directions, and we MDDers would like to thank them for standing us back up. But now we’re back and our first target after the layoff is, of course, FDA....

Did you miss us? We certainly missed sharing our thoughts with you via the Medical Daily Perspectives blog. Due to some seriously migraine-inducing computer hardware compatibility issues between the servers at Thomson Reuters and our old ownership, we have been on a forced blogging holiday since this past December. Now we are back, and dedicated to providing you with the most informative, topical and seriously fun blog that we can muster. We hope that you will continue to visit this site on a regular basis, and we pledge to update it frequently. We also encourage you to register and comment...

We all know power struggles are part of life, but not all struggles for leverage are created equal. Following are three stories that tell us something about leverage and its many uses. Interagency conflict over Intermacs? The Centers for Medicare & Medicaid Services recently announced it would no longer require hospitals to forward data from their patients with ventricular assist devices to the Intermacs registry. Depending on whom one asks, that’s a plus for hospitals, but the flip side of that particular coin is that another registry will have to take it’s place. The problem with CMS seeming to pull...

The number 23 is an interesting number. It’s a prime number, and is the number of pairs of chromosomes in human DNA, but it may also become a number FDA won’t soon forget. FDA recently issued a warning letter to 23andMe, ordering the company to stop offering its gene testing service pending further evaluations of the tests. Then a petition popped up at the website for the White House to require FDA to back off. The petitioners argue the agency “grossly overstates the risks” associated with the test, adding that consumers understand those risks. I won’t pretend to know what...

‘Tis the season to be thankful and slice into a roasted turkey with family and friends. In the spirit of the occasion, here are a few things I’m thankful for, and a few turkeys I think we could all do without. Thankful for: Some of the retooling of the device review process at FDA’s device center. These changes were long overdue, but we should acknowledge the agency’s budget was pretty flat for large parts of the first decade of this still-young century. It’s not easy to overhaul something on a flat budget, especially when it’s flat even before accounting for...

It is fall here in the U.S. and, for many Americans, that time of year brings cooler weather and football. Apologies to our non-U.S. readers, I realize that you have ownership on “real” football, and our version is secular at best. But, hey, football is ours and we sure do like it. It is during this time I like to reflect and “brag” that I have something in common with arguably one of the greatest quarterbacks to play the game – certainly in the modern era. You see, Peyton Manning and I share a common bond. No, my father...

America is the fattest country in the world. The obesity epidemic is one of the largest problems facing the healthcare system, both from a clinical and an economic perspective. Pardon the pun. The Centers for Disease Control and Prevention reports that more than one-third of U.S. adults (35.7%) are obese. Because obesity is associated with so many other health problems, such as heart disease and diabetes, the topic has drawn a great deal of attention at industry gatherings, including the Cleveland Clinic Medical Innovation Summit last month where the clinical focus was on obesity, diabetes, and the metabolic crisis. But...