Transforming FDA LogoMedical device companies are fine with paying higher user fees as long as it leads to a more predictable, streamlined process, reports the Record of Hackensack, NJ. "Enactment will help ensure that the agency has the resources necessary to fully evaluate medical device and diagnostic innovations and provide patients with timely access to medical technologies that can improve and save lives," a Becton Dickinson spokeswoman told the paper. Yesterday's public meeting on MDUFMA II did not produce any news of significance, according...
May 2nd, 2007
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A study published in the journal Circulation reveals that one in five implantable cardioverter-defibrillators stop working properly after 10 years, reports Bloomberg News. The biggest culprit is malfunctioning leads. Data from the study show that failure rates rose with time and affected all models. As of this morning, the companies that make ICDs had not responded to the findings. Until better lead technology is invented, might we have to look at ICDs like we do artificial hips -- a technology with a shelf life that must be replaced if the patient outlives it?
May 1st, 2007
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In ruling on a case called KSR v. Teleflex, the U.S. Supreme Court today struck down its previous standard of "obviousness" and came up with a new standard that is expected to make it harder to obtain patents and easier to challenge their validity. The medical device industry, much of whose value derives from patents, needs to take note. The San Francisco law firm Morrison...
April 30th, 2007
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Today is the public meeting on the new version of the Medical Device User Fee and Modernization Act, which must be passed by Congress by the end of September. If there is any potential stumbling block to its passage, it will likely come out in this meeting. Hopefully nothing will emerge to block the proposal, which increases but stabilizes user fees and delineates much more sensible performance goals for FDA. The meeting location has been changed to FDA's White Oak site in Silver Spring, MD, due to flooding at the original site.
April 30th, 2007
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Becton Dickinson (Franklin Lakes, NJ) wants to get a test on the market that can tell the difference between regular staph infections and drug resistant forms in just  read more >>
April 27th, 2007
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Much has been written today about a New England Journal of Medicine article that nine in 10 doctors accept gifts from drug and device companies. Of course that has prompted more hand-wringing over whether the ties between clinicians and industry are too close. But there is little mention of the benefits of these ties. I can't speak to the drug industry, but yes, ties between doctors and device companies do bring benefits to patients. Device development is necessarily an iterative and collaborative process between doctors and device companies. Doctors have to be able to use the device in order for it to work -- and thus there are legitimate reasons to have doctors involved in product design, or serve as consultants, or what have you. The same is not necessarily true for drugs. But as usual, the coverage offers almost no distinction between the drug industry and the device industry, even if doctor-industry ties are much more justified for devices. In fact, the only voice of reason...
April 26th, 2007
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A blood test under development may detect more prostate tumors than the current test, and could eliminate thousands of unneeded biopsies, reports the Washington Post. The test, EPCA-2, is being developed by Oconome, Inc. (Seattle) and a research team at Johns Hopkins University (Baltimore). The current test, PSA, produces a lot of false positives, and 80% of the biopsies that result from it come back negative. A study published yesterday in the journal Urology suggests that EPCA-2 is better than PSA at finding real positives and avoiding false positives. For those who are keeping score about when the media cites device companies when there is a medical breakthrough, the Post piece does give credit to Oconome, but not until the eighth paragraph.
April 26th, 2007
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In a release published on devicelink.com, Medtronic announced that it has exercised its option to acquire the O-arm Imaging System from Breakaway Imaging LLC. Terms of the deal were not disclosed. The system will be added to the image-guided surgery portfolio at Medtronic's Navigation division. Medtronic believes it has potential for use in minimally invasive spine surgeries, among other applications. The system provides surgeons with 3-D images, as well as multi-plane 2-D, and fluoroscopic imaging.
April 25th, 2007
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Venture investing in the first quarter of 2007 was at its highest level since the end of 2001, which is great news for medical device startups. Medical device firms garnered more than $1 billion of the $7.1 billion invested by venture firms from January to March of this year, according to a MoneyTree report featured in the Boston Globe. Analysts believe that large device companies are turning to smaller ones for innovative products to keep the pipeline flowing, mirroring a similar trend involving large drug companies and small biotech ones.
April 24th, 2007
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The Boston Globe has a piece analyzing the Boston Scientific-Guidant deal one year after it was consummated, and it comes to some unexpected conclusions. A number of investors and analysts believe the company is stronger today because of the deal, because it would have been significantly weakened without it. The market for its core business before the deal, stents, has declined over the past year thanks to studies that have questioned their safety and efficacy. Whereas the market for implantable heart devices has started to rebound over the past year. So, while the much-maligned deal has not achieved what Boston Scientific management hoped for, it has made the firm much healthier than it would have been had it continued to rely on stents so heavily. CEO Jim Tobin is quoted as saying Boston Scientific would be in "deep doodie" without Guidant. If he's willing to...
April 23rd, 2007
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