Author Archives: Mark McCarty

ACC 2018: Data for Heartmate 3 suggest a study against transplants

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…

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ACC 2018: Five-year Corevalve data closely track SAVR outcomes

By Mark McCarty, Regulatory Editor Five-year data for novel cardiology devices are often unavailable before that iteration of the device has become obsolete, but those data are nonetheless important. Hans Gustav Thyregod of Copenhagen University Hospital reported five-year data for…

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ACC 2018: ICD vest associated with lower all-cause death, but not SCD

ORLANDO, Fla. − It’s always difficult to explain why a device therapy reduces overall mortality without affecting mortality for the condition under treatment, but that’s the dilemma facing the trialists involved in the study of a lightweight defibrillator vest that…

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Carryover; Two 2017 Stories for 2018

2017 was quite the year in terms of device regulations, but payers had an interesting time of it as well. Following are a couple of developments that promise to carry over into the new year, with unpredictable consequences. Tapping the…

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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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