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There are a lot of ways to save money without going bankrupt in the process, but health care in the U.S. certainly has not lent itself to that sort of thing. Still, there’s a big opportunity to do just that if one demonstrates an interest in sleep, a subject about which there is little evident interest in Washington, D.C., or in the boardrooms of med tech firms. According to a study by the Rand Corporation, data from five OECD nations suggest that those who sleep...
Now that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low surgical risk, it’s tempting to think this device type has pretty much conquered all that lay before it. That’s not the case, however, as the question of bicuspid valve might be answered in a way that gives Edwards Lifesciences and Medtronic another sizeable patient population for their TAVR offerings. As is widely known, the FDA recently approved two TAVR devices each by Medtronic...
We who write about medical devices rarely suffer for content, but the month of May was unusually cooperative even by our standards. Following are two stories about medical devices that either emerged or resurfaced in the merry month of May, each of which involves a cardiologist and what some of us now think of as not-so-social media. Cabana and the case for catheter ablation We’ve all heard at least a little of the noise about catheter ablation for atrial fibrillation over the years, including assertions...
Life has a lot of unknowns, and one of the big unknowns for 2019 is what the FDA will look like now that Scott Gottlieb has returned to the American Enterprise Institute. Norm Sharpless of the National Cancer Institute has been named the acting FDA commissioner – which by itself doesn’t mean a whole lot, other than that he has to be considered a lead candidate for the job – but the difficulty in knowing where the agency would go in terms of policy under...
Now that the dust is still swirling over the news that Scott Gottlieb will leave the FDA, it’s time to conduct a hasty post-mortem on his tenure at the agency, or perhaps more to the point, his lack of tenure. While it’s tempting to frame the question that way, it might be more salient to ask about the nature of the FDA commissioner’s job and whether it is still sufficiently politically insulated to do what is asked of it. Gottlieb had been on the job...
A now-little known band called the Classics IV made a big splash in 1968 when their Hallowe’en love song “Spooky” charted at #3 on the U.S. Billboard Hot 100, and eerie though it may sound, there might be a lesson in there for the FDA half a century later. Sound preposterous? Read on and decide for yourself. House (and Senate) on Haunted Hill As we’ve all seen, the FDA has proposed to pull the substantial equivalence standard for 510(k) filings, but the agency also acknowledged that these 510(k) submissions have ballooned over the past decade or so. Some of that...
When things go awry, we often hear the rather dubious claim that goes something like this: "I hate to say I told you so, but..." Truth be told, that's silly. We love being able to say we told you so. We're human! In that spirit, when it comes to the FDA's recent announcement about getting rid of the substantial equivalence standard for 510(k) devices, let me say this: I told you so. To recap, the latest set of FDA proposals regarding the 510(k) program, including a rather oafish doing-away with the substantial equivalence standard, have drawn a lot of ink...
As device makers know all too well, the acronym NSE means not substantially equivalent, which is not the desired outcome in connection with a 510(k) filing. However, there’s another predicament that doesn’t look substantially equivalent, either. That’s the function of the FDA pre-certification concept and the 510(k) program as a whole. The reason this lack of equivalence is topical at this moment in regulatory history is that even a casual reading of recent tea leaves suggests that the agency is yet again on the march in an effort to excise the...
There's more to med tech than just money, but it's pretty tough to do much without it. Consequently, money is topical, but one expert sees a more difficult road ahead than anticipated for investors in digital health, while another says device makers are missing out on several opportunities to do their coffers some good on their way to market. Healthy skepticism over digital health Developers of digital health applications may be jubilant regarding the FDA’s efforts to modernize its approach to these virtual medical devices, but the new proposal regarding a full-fledged digital pre-cert program...
By Mark McCarty, Regulatory Editor Some devices are just the latest and best in class while others force clinicians to revisit long-held assumptions about the possibilities of a device type. This appears to be the case with an interim report of data from a study of the Heartmate 3 device, which not only handily bested the Heartmate II for freedom from disabling stroke at two years, but also prompted one observer to ask whether the time has come to try a left ventricular assist device against transplantation. Mandeep Mehra...
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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