Edwards Lifesciences (Irvine, California) is in a peculiar state of affairs, having won over an advisory committee recommendation for its Sapien transcatheter aortic valve, but watching its shares lose 5% or more of their value in mid-day trading last Friday. The incidence of stroke was an issue during the hearing, but FDA is looking for two post-approval studies, one of which is sure to require a lot of additional money and time (Medical Device Daily, July 22, 2011). (Medical Device Daily)

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...

GAITHERSBURG, Maryland – Anyone responsible for delivering news to those who invest in shares of Edwards Lifesciences (Irvine, California) might have resorted to the cliché, "I have some good news and I have some bad news." The good news is that an FDA advisory committee voted 9-0 (with one abstention) that the benefits outweigh the risks associated with the firm's Sapien aortic valve, an outcome that was anticipated by the markets after FDA posted documents associated with the application earlier this week (Medical Device Daily, July 19, 2011). (Medical Device Daily)

In this blog, we've explored the issue of NIH funding twice. The first time, we examined the reported fiscal spending numbers (here) and the second time, we examined funding by program areas (here), but now we have the budget/deficit ceiling debate, and yet we still see examples of truly nonsensical arguments about NIH funding. Let's acknowledge at least one thing: It makes no sense to fatten the NIH basic research pipeline when we know FDA can never keep up with it. It's akin to putting up a larger water...

We all find ourselves immersed in our work at times, but some jobs have tremendously broad appeal while others don't. For instance, lots of people want to own a vineyard, but even people who don't care for the idea like to talk about wine. In comparison, there are people like me whose heads are full of things most people don't care about. One day a few months back, I sauntered about mulling over the med-tech policy ramifications of something or other. Some time later, I noticed...