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Is the sky falling? Device makers keep saying so By MARK McCARTY Medical Device Daily Washington Editor FDA's Center for Devices and Radiological Health is certainly on a regulatory tear of late, and industry is understandably rattled by some of the developments. After all, CDRH only recently managed to shed a couple of obvious malcontents in the persons of Robert Smith, MD, and Julian Nichols, MD, who both worked at the Office of Device Evaluation at CDRH and were not exactly happy to get their walking papers. My impression is that you have to be either really obnoxious, noticeably incompetent,...
Dust storms - like this picture my husband sent me today from Iraq - are a regularly occurring nuisance in the Middle East. As this is Andrew’s third tour of Iraq, I've seen many photos like this one over the last five years that illustrate just how thick the dust actually is over there. I can’t help but think this might be the culprit behind the mysterious respiratory illness Andrew has suffered repeatedly from just since his first Iraq deployment. Although the military doctors he has seen have never been able to diagnose the problem, he has complained of breathing...
A couple of weeks ago I interviewed PixelOptics' president/CEO Ron Blum, about a technology called emPower, a device that could eventually replace bifocals. Now there's one thing you need to know about the interview. Blum is one of those people that med-tech journalists just love to talk to. He’s honest, upfront and has a sort of passion about his product that you just don’t see that often. He’s not regurgitating facts, or bedazzling you with technical terms that can sometimes go straight over your head. But rather, Blum is a master of his craft. And if emPower is anything like its...
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...
A story about DSM Biomedical (Berkeley, California) that appeared in Thursday’s issue of Medical Device Daily drew a comparison between companies like DSM and the film industry’s production crew that works behind the scenes adding invaluable elements to help make the movie a success but are much less recognized and appreciated than the starring cast members. So just for fun let’s imagine what it would be like if the med-tech industry had its own televised version of the Academy Awards. Instead of an Oscar, the coveted trophy would resemble a big gold stent. Before the show CEOs from big players...
For nearly eight years my mother has been on anticoagulants. Because of this, she has to drive down to her local hospital every two weeks or so and clinicians test her blood to see if she is in danger of developing a blood clot. In theory it seems pretty simple, and pretty painless. But in reality it can be pretty taxing. Although the visits last 20 minutes or so, my mother has had to plan her life around these “events.” Vacations have been cut short and travel plans now almost always include looking for an institution that will be able...
I’m not proud to admit this, but once in a while I do get bit by the green-eyed monster – only when it comes to medical innovation though. Hey, nobody’s perfect – right? About eight years ago I had major colorectal surgery following a pretty wicked battle with ulcerative colitis. Basically the surgeon had to take out my entire colon, creating a stoma (artificial opening in the abdomen wall through which the end of the intestine is brought). I wore an ileostomy bag for 15 months before having a “take down” surgery so that I no longer needed the bag...
President Barack Obama unveiled his deficit reduction plan last week, calling for a mix of spending reductions and tax hikes that the White House claims would cut federal deficits by $4 trillion over the next 12 years without gutting popular programs such as Medicare and Medicaid, a challenge that may be difficult to achieve given the level of debt in the U.S. Obama's plan calls for a repeal of the Bush-era tax cuts on families making more than $250,000 annually. The president also called for the creation of a "debt fail-safe" trigger that would impose automatic across-the-board spending cuts and...
(For those who wonder whether Congress will ever pass a patent reform bill, we offer the following with a tip o' the hat to Edgar Allan Poe....) Once upon a mid-day dreary, While I pondered dazed and bleary, O'er forgotten writs of Federal Circuit law and patent lore. Yes, I nodded, nearly napping, But then came a nagging tapping. Some optimist was gently rapping, Rapping at my office door. "'Tis some fool," I think I muttered, "Waxing over writs of yore, Only this, and nothing more." Ah, distinctly I remember, It was back in some December, When each separate Senate...
LONDON – It’s no secret that American citizens pay the most for drugs, but the extent of the disparity is laid bare in a new index of the prices of 13 medicines...
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s...
Commissioner of the FDA for five years starting in 1984, Frank Young relished his position “at the vortex of controversy” as he sought to deal with the AIDS...
After being in the doldrums for the majority of the year, public biopharmaceutical companies, it appears, have turned the corner and are now on a major upswing.
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