Author Archives: Mark McCarty

Device flight round trips, and other matters

Never a dull moment in the world of medical devices and the Food and Drug Administration, is there? Sometimes the FDA is on the march, other times it seems the agency is about to be eclipsed by other forces. Don’t…

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Loose the clown posse; Uncle Sam has cancer fever

You have to hand it to the cancer lobby. It really has the U.S. federal government wrapped around its little finger. Some will say I’m overstating the case, but is that really a solid argument? Let’s examine the evidence. Mortality,…

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ACC 2016: All aboard the TAVR train

The Windy City really lived up to its name during the course of ACC 2016, didn’t it? It was also interesting to hear the recording on the subway stating that gambling is not allowed on the trains. Who knew? ACC…

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To IVUS or not to IVUS

Everyone has heard about the FDA advisory hearing for the Absorb scaffold by Abbott Vascular, but to recap, one of the issues that came up in connection with the trial data for the Absorb was the association between coronary artery…

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Abbott’s dilemma; Absorbing the Absorb

Now that Abbott Vascular has pulled out a resounding win at an FDA advisory committee for its Absorb bioresorbable scaffold, it’s time to ask what the coverage and reimbursement pictures look like. The coverage part looks easy – perhaps easier…

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FDA’s thumb on the scale

It’s often interesting to see and hear the things that go on at FDA advisory hearings, and the Feb. 18 hearing for leadless pacemakers proved to be no exception. I’ll admit at the outset that I’ve always been of the…

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POTUS, cancer and shooting for the moon

It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to…

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FDA detention and other feel-good stories

Device makers like to grouse about FDA, but they’re not the only ones who feel they have an axe to grind. Recent warning letters suggest the agency is more frequently making use of detention to deal with violative products of…

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The device tax; down and out or just down?

2015 was another of those years with some interesting developments, some good, some bad. The biggest news of the year is that the device tax has been suspended for two years as a result of the budget deal between the…

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Thursday two-fer from Medical Device Daily

Disc jockeys like to do two-for-Tuesdays and three-for-Thursdays, but we’re not spinning music at MDD Perspectives. Today we go into full rebellion mode by offering a Thursday two-fer. Take that, hegemonistic radio stations! MAC, re-MAC, and MAC again Writer Jim…

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