The new year is underway and a few things of interest to med tech firms have already cropped up. Here are three of the more interesting developments in the world of medical devices (and it’s only for the month of January). Duval files petition to stay substantial equivalence guidance I’ve never filed a citizen’s petition, but something tells me it entails more work than making a cup of coffee, so I’ll assume that regulatory consultant Mark Duval thought he was on to something in filing a petition to have FDA...

Device makers are rightly concerned about the viability of Medicare in the coming decades, but there’s a tremendous amount of pressure on the program right now. For instance, budget sequestration will shave 2% off the monies paid out for Medicare by the end of March unless our elected officials can come to some agreement, but we no longer talk about least costly alternative (LCA) because it’s purportedly kaput. The idea that LCA is kaput, however, might not be accurate, and there are a couple of reasons industry should stay...