Category Archives: Uncategorized

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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Closing the Absorb chapter

Two years ago, my youngest child was just learning how to walk and analysts were praising Abbott Laboratories’ bioresorbable vascular scaffold. Flash forward today – my son is riding his bike like a true champ (with training wheels) and Abbott is …

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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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Is open source the future of pharma and med tech, or an anomaly?

Technology seems to leap ahead at an astounding pace and is disruptive for many businesses, but is achingly slow for patients who await disease detection and treatments. A recent TED Radio Hour, “Fighting Cancer,” included speakers who addressed their approaches…

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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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Augmented reality check

My first real exposure to what’s commonly called augmented reality was about a year ago when one of my former colleagues introduced me to Pokemon Go. I remember her telling me that you could actually hold up your smartphone or…

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Tech reflects our humanity

When my now middle-aged dog was a puppy, I looked into taking him to basic obedience classes. At one of these sessions, a group of newbie pet owners gathered in a room tucked into the back of a pet store….

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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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