I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

Anyone who reads this blog on a regular basis knows I'm leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to give FDA the once-over once again, this time over the agency's omissions regarding social media. As readers of Medical Device Daily know, the Center for Devices and Radiological Health has proposed using social media for compliance and enforcement activities, which I covered in the Oct. 7 edition. I should...

  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...

Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion. But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer...

  The title of this posting pretty much says it all, but I'm paid to tap out words on my keyboard. So here we go. Remember FDA's draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device's filing. So what's a device maker to do? Cite every potential predicate it can. Why? You have to ask? Yes, yes, FDA wants to cut down on the use of...

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...

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...

The deal struck by Medtronic (Fridley, Minnesota) regarding an evaluation of adverse events associated with off-label use of the InFuse bone morphogenic protein is conspicuous, but not so much because it will cost the firm $2.5 million to have Yale University (New Haven, Connecticut) review the data, as reported in the Aug. 5 edition of Medical Device Daily. As described by MDD managing editor Holland Johnson, this effort will be made very public and is being touted as a new level of transparency that may set the standard for future such activities. In the meantime, however, it might be enough...

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...

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...