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BioWorld - Friday, February 26, 2021
Home » Blogs » BioWorld MedTech Perspectives

BioWorld MedTech Perspectives
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Health care and politics illustration

U.S. politicking threatens public trust in the FDA and CDC

Aug. 26, 2020
By Mari Serebrov
The truth that every action has a reaction is being proven again in the public square of the U.S. as the shrill, endless clamor of politicians hoping to score against their opponents via health care issues or accomplishments threatens to undermine confidence in the FDA, the products it approves and even the guidance offered by the Centers for Disease Control and Protection (CDC). In the past, politicians from both parties blamed “greedy” biopharma companies and self-appointed social influencers for patients refusing to fill prescriptions, get tested or be immunized. Now they have themselves to blame.
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Speech bubbles

The demise of the device tax and other fun med-tech stories

Jan. 7, 2020
By Mark McCarty
It’s mighty tempting to run a little play on words with regard to eyesight in this new year, but I need reading glasses, so far be it from me to pepper a blog with wisecracks about 20-20 vision in 2020. Still, there are a few things to look forward to in this new year, including some great expectations and one or two desperate hopes.
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awake in bed illustration

Missed Opportunity: The epidemic of poor sleep

Sep. 19, 2019
By Mark McCarty
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...
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Next up for TAVR: bicuspid valve

Aug. 27, 2019
By Mark McCarty
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...
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cabana hut

Cabanas and commissioners; med tech in the news

May 30, 2019
By Mark McCarty
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...
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sharpless headshot

FDA’s new man of regulatory mystery

April 30, 2019
By Mark McCarty
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...
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revolving door sign

Scott Gottlieb and the FDA’s revolving door problem

March 7, 2019
By Mark McCarty
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...
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Four “Spooky” ways to fix the 510(k) dilemma

Dec. 13, 2018
By Mark McCarty
No Comments
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...
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Substantial equivalence revisited

Dec. 5, 2018
By Mark McCarty
No Comments
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...
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NSE; Pre-cert and the fate of the 510(k) program

Aug. 29, 2018
By Mark McCarty
No Comments
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...
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