Medical Device Daily

Buck for the bang: Premium med-tech pricing

October 31, 2011 – 6:58 AM | By Mark McCarty | 1 comment

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By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group

Posted in CMS, FDA, Medicare, Reimbursement, Uncategorized | Tagged , , ,

A whole new world

October 28, 2011 – 9:44 AM | By Amanda Pedersen | No comments yet

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me.

Posted in Comparative effectiveness, FDA, Heath Information Technology, Heathcare Reform, Intellectual Property, Medicaid, Medicare, Reimbursement | Tagged , , , , , ,

Arguments aside, PSA test makes great sense to one who intends to keep on having it done annually

October 26, 2011 – 9:15 AM | By Holland Johnson | 1 comment

By JIM STOMMEN, Medical Device Daily Contributing Writer

Posted in Diagnostics, Oncology | Tagged ,

A regulatory landmine: FDA and social media

October 24, 2011 – 5:45 AM | By Mark McCarty | No comments yet

[caption id="attachment_998" align="alignleft" width="238" caption="One little misstep is all it takes"][/caption]

Posted in CDRH, FDA, Uncategorized | Tagged , , , ,

Why isn’t more preventative healthcare covered by insurance?

October 21, 2011 – 5:30 PM | By Holland Johnson | No comments yet

I went to see my doctor a few weeks ago for a physical. Since I just turned 40, he recommended that I have a CT scan to check for calcification in my heart valves. Maybe I would have said  "no," when he mentioned that the cost would not be covered by insurance, but his cautionary tale about a person he knew who had collapsed and died of a heart attack at the age of 42 persuaded me that maybe this was a good idea after all.

Posted in Heathcare Reform, Hospital, Imaging | Tagged ,

Parallel review: Still not a big deal?

October 11, 2011 – 7:14 AM | By Mark McCarty | No comments yet

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year.

Posted in CDRH, CMS, FDA, Federal Deficit, Medicare | Tagged , , , ,

A really bad idea: FDA conducting CE research

October 6, 2011 – 8:12 AM | By Mark McCarty | 1 comment

The question of whether FDA should shoulder the burden of comparative effectiveness research crops up from time to time, but there is more faith in the appropriateness of that notion than I believe is warranted. I only bring this up because Steve Grossman of the Alliance for a Stronger FDA (Washington) raised the issue recently at the Gooznews blog. So let's take a quick look at this issue and examine the question of not just whether FDA is sourced to do this, but whether it should even consider such a task.

Posted in AHRQ, Comparative effectiveness | Tagged ,

Some paper along with those EHRs please …

October 6, 2011 – 6:00 AM | By Omar Ford | No comments yet

Frustration could not even begin to describe the look on my mother’s face during a recent trip to a local lab here in Atlanta to get some diagnostic tests run.

Posted in Heath Information Technology | Tagged

A tinkerer at heart, Wilson Greatbatch epitomized what that means to medicine

October 4, 2011 – 11:19 AM | By Jim Stommen | No comments yet

A prolific inventor who died last week in upstate New York at the age of 92, Wilson Greatbatch is credited with more than 325 patents, including coming up with the first practical implantable pacemaker.

Posted in Cardiovascular | Tagged , ,

Patent reform in search of respect

October 3, 2011 – 9:46 AM | By Mark McCarty | No comments yet

We who scribble for a living find it easy to go off on those who do not, and today's bulls-eye is on the patent reform bill recently signed into law, the America Invents Act of 2011.

Posted in Intellectual Property, Patent and Trademark Office, Patents | Tagged , , ,

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