Author Archives: Mark McCarty

Abbott’s dilemma; Absorbing the Absorb

Now that Abbott Vascular has pulled out a resounding win at an FDA advisory committee for its Absorb bioresorbable scaffold, it’s time to ask what the coverage and reimbursement pictures look like. The coverage part looks easy – perhaps easier…

FacebookTwitterGoogle+Share

FDA’s thumb on the scale

It’s often interesting to see and hear the things that go on at FDA advisory hearings, and the Feb. 18 hearing for leadless pacemakers proved to be no exception. I’ll admit at the outset that I’ve always been of the…

FacebookTwitterGoogle+Share

POTUS, cancer and shooting for the moon

It was interesting to hear the President become archly ambitious about the oncological equivalent of a moonshot during his most recent State of the Union address. The President said veep Joe Biden would take the lead on an effort to…

FacebookTwitterGoogle+Share

FDA detention and other feel-good stories

Device makers like to grouse about FDA, but they’re not the only ones who feel they have an axe to grind. Recent warning letters suggest the agency is more frequently making use of detention to deal with violative products of…

FacebookTwitterGoogle+Share

The device tax; down and out or just down?

2015 was another of those years with some interesting developments, some good, some bad. The biggest news of the year is that the device tax has been suspended for two years as a result of the budget deal between the…

FacebookTwitterGoogle+Share

Thursday two-fer from Medical Device Daily

Disc jockeys like to do two-for-Tuesdays and three-for-Thursdays, but we’re not spinning music at MDD Perspectives. Today we go into full rebellion mode by offering a Thursday two-fer. Take that, hegemonistic radio stations! MAC, re-MAC, and MAC again Writer Jim…

FacebookTwitterGoogle+Share

Medicare’s Buster Keaton moment and other tales

It takes a real grown-up government agency to admit when it has bungled the job, or maybe it just takes a good thrashing in the court of public opinion. Of course, there are government agencies that simply mumble into their…

FacebookTwitterGoogle+Share

Tax talk: 2017 or bust

FDA’s device center is busily punching up draft guidances again, but today we’re back into the faces-and-places discussion just like last time here at MDD Perspectives. This time, the churn is on Capitol Hill, which is also where two tax…

FacebookTwitterGoogle+Share

Room at the top; FDA, AdvaMed seeking new leadership

The policy realm of medical devices is rarely quiescent, but the current pace of activity is conspicuous. There are a couple of juicy legal issues churning these days, but we’re also watching a changing of the guard at some pretty…

FacebookTwitterGoogle+Share

Sacked: FDA and CMS taking hits

There are times when we in the private sector think you have to be crazy to want to work at FDA or CMS, but the true unemployment rate is still in excess of 10%. Who in their right mind is…

FacebookTwitterGoogle+Share

Marketo