Author Archives: Mark McCarty

Second bites and second sights: A summer med tech trifecta

Rock and roll radio stations used to tout their two-for-Tuesday and three-for-Thursday lineups, but we at BioWorld MedTech think every day is good for a threefer. Below are three stories of recent vintage to grace the pages of BWT, at…

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Summer love; med tech ‘court-ship’ heats up

Louis Armstrong’s Summer Song evokes an inviting and mellow season, but a leisurely pace can be a pain in the neck for a med tech writer. The FDA’s device center might not be pumping out guidances of late, but the…

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Indispensably obsolete; the FDA warning letter

The FDA warning letter has been around for more than a quarter century, and questions about their use and abuse crop up periodically. Perhaps it’s time again to ask whether warning letters actually fulfill their purpose, but one gets the…

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Quick hits from ACC 2017

The news at ACC 2017 has varied by product type, including TAVR devices, coronary artery stents and imaging modalities, As usual, there are potential and verifiable winners and losers, and in some cases, companies playing catch-up with the competition in…

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FDA issues alert for Abbott GT1 due to MACE rate

The FDA issued a Medwatch alert on March 18, regarding the rate of major adverse cardiac events for the Absorb GT1 scaffold by Abbott Vascular, breaking an embargo placed on the news at the American College of Cardiology annual meeting….

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FDA’s off-label dilemma

As is widely known, the FDA is facing a change in leadership and has inked a memorandum staking out the agency’s current position on the off-label promotion problem. Despite the continued vetting of the problem by the agency, the memo…

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Hyperventilation; Reaction to the Cures Act

  There may be someone on the dark side of the Moon that hasn’t heard about the Senate vote for the 21st Century Cures Act, but everyone else certainly has. One might have expected the reaction to the Cures bill…

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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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