November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely, stress-free drive or comfy, un-cramped flight to celebrate Thanksgiving with loved ones. CMS makes a virtue of necessity The final guidance for the Medicare coverage with evidence development (CED) program is a relatively brief document considering the impact it will have, but also considering the length...
There’s rarely a lack of activity on the policy and regulatory fronts in the world of med tech, and the past couple of weeks are no exception. Let’s talk about a few of those developments. Consequences or tea leaves? President Obama said in 2009 that elections have consequences, and that’s certainly true. But that’s a very different proposition than declining to “read the tea leaves on election results,” isn’t it Mr. President? (And then there’s MIT’s Jonathan Gruber extolling the virtues of a lack of transparency, not...
So what were the major talking points coming out of Cleveland Clinic's Medical Innovation Summit? It certainly wasn't a discussion on the lack of venture capital dollars available for med-tech start-ups - a topic that used to dominate conversations a few years back. Nor was it about the Affordable Care Act. No, the major talk at this year's Medical Innovation Summit, which was held last week, revolved around companion diagnostics. Look for new and exciting pharmaceuticals to be married to diagnostic tests for the foreseeable future. It seems in nearly every other panel something about combination diagnostics was mentioned. One...
The life sciences have fostered an environment that can get pretty crazy, but let's face it: That's one of the things we like about the life sciences. Below are two stories that rival the tallest tales told of the Old West, but these two stories happen to be true stories. Hamburg; clinical trials for Ebola The latest outbreak of Ebola has generated a few rhetorical whoppers by elected and appointed officials. One of the weirder among them is a remark by FDA Commissioner Margaret Hamburg, who said in...
Physicians and surgeons are going to flock to Google Glass. That's my bold prediction and I'm sticking to it. I mean come on, just look at the impact the i-Pad has had on healthcare facilities across the country - sorry world. Now one of the main reasons Google Glass is going to make a strong impact, is because of it gives surgeons access to patient information and apps, at the benefit of freeing up the physician's hands. It's a common sense selling point, that I missed when I demo-ed the technology about a year ago. But what brought this fact...
There is certainly no shortage of stories (or controversy) in the world of med tech, and here are a couple of stories that kept a lot of people glued to their computer screens (more or less) recently. FDA watches the Watchman FDA has heard a third affirmative vote from an advisory committee on the question of the Watchman left atrial appendage closure device, although the vote in favor of the device was close for the second consecutive time. It’s an interesting predicament for the agency because members of...
The annual meeting of the Advanced Medical Technology Association, or AdvaMed, doesn’t include a lot of mind-blowing news, but there are often developments worthy of note. Following are a trio of stories addressing what was (not) said, and a few things to watch for over the next year or so. Physician payment sunburn? As reported by Medical Device Daily executive editor Holland Johnson in the Oct. 8 edition of MDD, Covidien’s chief medical officer Michael Tarnoff had a few interesting observations about sustainability. Tarnoff said docs are accustomed to getting what...
As is widely known by now, FDA lost the second round of the legal struggle over the Menaflex 510(k), but the decision at the Court of Appeals for the District of Columbia sends the application back to FDA, where the device awaits an uncertain fate. Will FDA appeal to a higher court? I doubt it. The Menaflex story is one of the more convoluted med tech stories of the recent past. The first sponsor of the product, the now-shuttered ReGen Biologics, initially filed it as...
Sometimes when I think about policy and regulatory matters in the world of med tech, I feel like I’m no longer in Kansas. Here are three stories of interest to device makers that might make one wonder who’s behind the curtain, and an icon of sorts for each. Jobs legislation; the Cowardly Lion The U.S. House of Representatives has passed H.R. 4, a bill that deals principally with jobs, but carries with it a repeal of the 2.3% medical device tax. So why is this bill a...
Baseball analogies are definitely overused, and now it’s my turn to abuse the privilege. Following are three stories in which somebody failed to reach base. Definition of a device One of the more interesting developments of late is the recall of a huge number of convenience kits assembled by Customed of Puerto Rico. FDA recently announced a recall of more than 200 of these so-called “devices,” but there’s something a little misleading about characterizing this as a medical device recall. So a convenience kit...
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