Author Archives: Mark McCarty

Small Changes; FDA and the 510(k)

Tom Waits once sang of a character named Small Change, who apparently “got rained on with his own .38,” and device makers might sometimes have felt as though small changes to their devices didn’t always work out so well, either….

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Accelerated; Language and the New FDA

We’ve all been witness to a variety of predicaments in terms of the FDA’s premarket review of biologics, drugs and devices, but while controversies abound, there’s also this nagging question of how words color perception. It’s an important consideration, one…

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Tempest Fugit; The 2017 MedTech Conference

This year’s med tech conference was a lot like previous years’ events, but the heat of the moment is always telling, isn’t it? Following are a few developments that were part of the conference by design or by chance, but…

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Rehash; FDA device inspections and the Guidant deal

As the summer doldrums draw mercifully to a close, we can look back over a more or less expansive period of time to see where we’ve been in some hope of divining where things might be headed. Or maybe it’s…

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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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