After efforts to recover from a huge corporate scandal, Tyco International is splitting up. The move will create three spin offs--Covidien, Tyco Electronics, and Tyco International. Covidien (Mansfield, MA) will become one of the largest medical equipment manufacturers in the world. According to the Newark Star Ledger, its sales of ventilators and respiratory management products increased 4.2% to $704 million during the first half of the year. The Boston Globe is also reporting that Covidien is making a clear effort to distinguish itself from the tarnished Tyco name via billboards and other advertisements. The company markets a range of healthcare products under brand names including Autosuture, Kendall Healthcare, and Syneture.
June 29th, 2007
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At a Senate hearing on industry gifts to doctors yesterday, some Senate Democrats said they would push for legislation that would create a federal registry of such gifts. The New York Times article about this is almost entirely about the drug industry, but it refers to "legislation that would create a national registry of gifts and payments to doctors by the makers of drugs and medical devices." Yet the uproar doesn't seem to be about medical devices; that was the only mention of them in the whole piece. The device industry's trade associations need to weigh in on this quickly.
June 28th, 2007
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A device that freezes part of the heart in order to stop abnormal heart rhythms has been recommended for approval by an FDA advisory panel, the Associated Press reports. The Cardiac Cryoablation System from Cryocor Corp. (San Diego) uses a catheter to send nitrous oxide into part of the heart. The nitrous oxide freezes tissues and creates lesions in the upper chamber that ablate areas responsible for the abnormal rhythms. Similar technologies are available that use radiofrequency energy instead of cold. The panel recommended that the company create a patient registry and conduct follow-up studies. The agency usually, but not always, follows the advice of its panels.
June 28th, 2007
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FDA announced it has cleared for marketing the Binax NOW Malaria Test, the first rapid test for malaria authorized for use in the United States. The test, made by Binax Inc., a subsidiary of Inverness Medical Innovations, Inc. (Scarborough, ME), can produce results in 15 minutes from a few drops of whole blood. It can also differentiate types of malaria. Previously, technicians had to examine blood samples under a microscope. While malaria is not common in this country, it is common in other parts of the world, and Americans who travel abroad may be susceptible to it.
June 27th, 2007
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Billion-dollar deals used to be pretty rare in the medical device industry. We would see one or two a year, usually for not much more than $1 billion. But the Boston Scientific-Guidant deal changed all that. Now any company of any size can be considered a potential acquisition, and a number of multibillion-dollar acquisitions have been made in the past 12 months. The Guidant deal may also have encouraged device CEOs to overspend, if they think their target is a particularly good fit. That may be the case with Roche Diagnostics, which according to Bloomberg News, has offered $3 billion to buy another diagnostics company, Ventana Medical Systems Inc. (Tuscon, AZ). That works out to $75 a share, which is a whopping 45% higher than Ventana's closing share price yesterday. Why would Roche pay that much of a premium? Because Ventana makes screening tests that...
June 26th, 2007
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Shelhigh Inc. on Friday settled its dispute with FDA over possible contamination of its tissue-based products, reports the Star-Ledger of Newark, NJ. It signed a consent decree to stop distributing products until it meets GMP requirements. It does not have to recall its products, as FDA requested, and can resume certain phases of manufacturing. But it does have to hire outside consultants to audit its facilities.

June 25th, 2007
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Bloomberg News reports that the Supreme Court has agreed to hear a case against Medtronic that could determine whether patients have the right to press product-liability lawsuits against firms with FDA-approved products. The court has declined to hear five similar cases since 2001. Medtronic and the device industry argue that FDA approval shields firms from liability lawsuits, and many lower courts have agreed. (This applies to PMA products; suits have been allowed to proceed against 510(k) and pre-1976 products, which are less rigorously reviewed.) The case involves a patient who had a Medtronic catheter burst inside of him during an angioplasty, and then required bypass surgery. Medtronic says the doctor was using the catheter off-label.
June 25th, 2007
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Medical devices are designed and tested for adults. How to use them in children -- and whether additional studies are required -- is a problem that has vexed medical device manufacturers and caregivers for decades. But today, according to the Boston Globe, a nonprofit organization is being launched to tackle those issues. Among the goals of the Institute for Pediatric Innovation is to work with children's hospitals to redesign devices to better fit children. The institute is based in Cambridge, MA and its first three hospital partners are based in California, Kansas, and Ohio. Up until now, the options for pediatric-use devices were not great. Either a device company could run expensive pediatric studies, or it could do nothing but sit back and watch hospital personnel improvise ways to use their products on children. Creating a systematic way to retrofit...
June 25th, 2007
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AdvaMed has announced a universal healthcare plan that would give all Americans the option of buying health insurance at an affordable price. Approved yesterday by the trade association's board of directors, the plan seeks to promote quality and the public reporting of provider and health plan performance, along with support for expanding IT in healthcare. It will also offer financial incentives for those providers and plans that give efficient care, especially related to chronic diseases. "Our plan shows you can finance expanded coverage without rationing care or stifling innovation," said AdvaMed President and CEO Stephen Ubl in a statement. AdvaMed estimates that the plan will save $226 billion in national spending and $105 in federal spending as a result of better treatment and disease prevention, medical innovation, and more use of health IT.
June 22nd, 2007
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Health care reform is traditionally considered the province of politicians, bureaucrats, doctors and other caregivers, insurance companies, and consumers. But the medical device industry is a stakeholder, too. With that in mind, AdvaMed later today will unveil its own health care reform plan. It says its plan will include universal coverage and a national multibillion-dollar fund to address health promotion and disease prevention. Most importantly to industry, the plan also includes "mechanisms to promote health quality, effiiciency, and innovation to help improve patient oucomes and control costs." In other words, a cost-control plan to serve as an alternative to gainsharing.  
June 21st, 2007
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