In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is not an exhaustive list of things that could arise in the last half of this year, but these are all pretty big, and a lot of people will be watching carefully. FDA meeting on IOM 510(k) report: FDA recently invited all interested parties to talk about the recommendations made recently by the Institute of Medicine regarding the 510(k) device clearance...

There's nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off. If you work for a firm intent on bringing a PMA device to market, FDA's insistence on a 1,000-patient post-approval study (PAS) for the Sapien transcatheter valve might have given you a bad case of deja vu because a small firm might not be able to get investors on board, even...

A few weeks ago, I made the mistake of going into the gym around 6 p.m. That's the time when all the body builders and athletes tend to circulate in the area. I also made the mistake of getting on the treadmill next to someone who obviously looks like he runs track for a living. After seeing him run close to 10 mph without breaking a sweat - and I was struggling to do six -  I left the gym dejected. The competition in there was just too great. How could I possibly keep up with someone who can do a mile...

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...

Top 10 reasons interventional cardiologists should be happy By MARK McCARTY Medical Device Daily Washington Editor Dear Interventional Cardiologist, Worried about Medicare reimbursement for the Next Great Stent? Concerned that FDA's massive regulatory girth will squash your drug-eluting balloon groove? Not to worry. Here are the top 10 reasons you should be thrilled with your choice of specialty. Number 10: PCI numbers are flat of late, but just watch that Baby Boom fill your waiting room in the years to come. Number 9: The transradial (through the wrist) route is gaining acceptance as an approach to coronary intervention. Number 8:...

Politics, economics, and NIH spending priorities By MARK McCARTY Medical Device Daily Washington Editor Government that makes sense. It's what we all dream of, but when it comes to spending priorities at the U.S. National Institutes of Health, we might as well wish to lose weight on the see-food diet. FYI: That's the diet on which when you see food, you eat it. What do I mean? Here's what I mean. NIH's budget for the National Cancer Institute in fiscal 2010 was a bit more than $5.1 billion (click here), but the budget for the National Heart, Lung, and Blood...

It’s easy to understand the excitement about the PARTNER trial, sponsored by Edwards Lifesciences (Irvine, California), the company that makes the much talked about transcatheter aortic valve replacement (TAVR) device, called the Sapien. After all, given the choice between open heart surgery or a non-surgical alternative most patients would prefer the latter. However, the data from the study, which was presented earlier this week at the American College of Cardiology (Washington) annual meeting in New Orleans, showed that TAVR patients were also more likely to have a stroke following the procedure. In the study, major strokes were higher for TAVR...