Top Device Companies

Medtronic To Fare Better Under Proposed Fee, Analyst Says

Medtronic is expected to fare better than many other medical device makers if a $2 billion annual fee on the industry survives in Congress, an analyst says. The Senate version of the legislation calls for fees to be imposed on device makers in 2011, based on sales this year. Of the 26 companies, Medtronic is the largest, itself with more net income in fiscal 2009 than the overall industry fee envisioned. The JP Morgan health-care analyst said smaller firms large enough they would be included in the fee would suffer more because most of their sales are in the United States and they have to reinvest more of their sales than larger makers. (Click here for more)

“Medtronic Hurt Least By Device Fee Compared To Competitors” – Finance & Commerce (12/31/09)

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“Medtronic, Boston Sci, Device Industry Get Reprieve For New Taxes

Medtronic, Boston Scientific and other device makers won a tax reprieve of sorts when the U.S. Senate fashioned the final version of health-care reform. The medical device industry still faces a phase-in of new federal taxes, rising to $3 billion a year by 2018. The beginning of the phase-in was delayed in the final version and currently is not to kick in until 2011. (Click here for more)

“Health Insurers Win Delay On Start Of $70 Billion In Added Fees” – Bloomberg (12/20/09)

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GE’s British Unit Uses Libel Law To Quash Criticism Of Its Omniscan

GE Healthcare’s U.K. subsidiary has gone to British courts to stifle talk questioning the safety of GE’s Omniscan drug used in its MRI scanners. A Danish radiologist had told a conference about his investigations into possible side effects of the drug, including potentially fatal responses to the drug. His talk led GE to spend more $607,000 pursuing the case based on a presentation to a conference in 2007. GE used British libel laws, based on its contention that while the drug has been linked to serious side effects in some patients, the company did not suppress information as the radiologist had contended in the 2007 talk at a British medical conference. (Click here for more)

“Drug Giant Uses Libel Law To ‘Gag’ Doctor Over Safety” – London Telegraph (12/20/09)

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Clarient Licenses Cancer-Testing Technology From Minerva

Clarient says it has licensed technology for testing for cancer from Minerva Biotechnologies for an undisclosed sum. Clarient said the test it acquired is an improved diagnostic for cancer capable of identifying the MUC1 protein, considered a biomaker for various cancers. Clarient said the test requires at least a year of development before its potential could be determined. (Click here for more)

“Clarient Licenses Potential Cancer Testing Technology From Minerva Biotechnologies” – Minneapolis Star Tribune (AP) (11/30/09)

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Titan Medical Ties With Canada’s CAE To Make Robotic-Surgery Systems

Titan Medical, Canadian maker of surgical procedures, has signed a partnership agreement with a maker of flight simulators to develop consoles for robotic surgeries. CAE, also of Canada, has a health-care division that seeks to use the company’s expertise to develop robotic-surgery platforms. The agreement, whose terms were not disclosed, would allow Titan to market the system eventually developed while CAE retains the option to be the only provider of training for Titan’s Amadeus robotic surgery system. (Click here for more)

“Companies Team Up To Develop Surgery Simulator” – Hamilton Spectator (Canadian Press) (11/28/09)

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Smith & Nephew President Among Device CEOS Who See Turn-Around

Smith & Nephew Endoscopy’s President Mike Frazzette is among medical device maker leaders who are becoming optimistic about business turning around soon. Makers such as Smith & Nephew saw declines this year due in part to fewer sports and travel-related injuries as Americans shunned vacations. Frazzette said hospital spending is beginning to resume. (Click here for more)

“Medical Device Firms Show Cautiously Optimistic Outlook” – Mass High Tech (11/20/09)

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Bayer, Covidien, GE MRI Agents Said To Risk Fatal Skin Disease

Bayer, Covidien and GE Healthcare have been advised by the FDA their MRI agents may be linked with an increased risk for nephrogenic systemic fibrosis, a potentially fatal skin disease. The products using the agents at issue are Bayer’s Magnevist, Covidien’s Optimark and GE’s Omniscan. Bracco Diagnostic’s Prohance and Multihance agents scored the lowest-risk as measured by the FDA. The agency said it planned to form a panel of outside experts to study the issue in December. (Click here for more)

“U.S. FDA Sees Varying Risk From MRI Agents” – Reuters (11/17/09)

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Hologic Hit By Panel Advice To Halt Routine Breast Scans For Under 50

Hologic’s digital mammogram system is expected to take the brunt of a government panel’s recommendation that routine tests not be given to women below the age of 50. Previous guidelines called for regular mammograms for all women beginning at age 40. The U.S. Preventive Services Task Force said it changed its recommendation because of the frequency of false positives in women in their 40s. At the same time, the task force said it could not discern if there were benefits for giving the mammograms to women 75 and older. Hologic said the suggestion to drop them for women in their 40s is not supported by solid medical evidence. (Click here for more)

“Hologic Slips As Panel Recommends Fewer Mammograms” – AP (11/17/09)

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Thoratec’s New Heart Pump Praised In Study For Survival Rate

Thoratec’s new-generation Heartmate II heart pump won praise from a comparative study of its effectiveness in improving survival rates. The study said the permanently implanted device quadrupled survival rates in patients with it for at least two years in contrast to older versions of the pump implanted only until a transplant could be performed. The lead researcher noted the high cost of Thoratec’s Heartmate II, at $80,000. Instead of just stimulating the heart to pump blood, the newer version does the pumping itself. (Click here for more)

“Study: New Device Improves Heart Failure Survival” – New York Times (AP) (11/16/09)

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Roche Gets Emergency Clearance For H1N1 Flu Diagnostic

Roche won U.S. FDA emergency approval for a diagnostic test for the H1N1 flu virus. Roche’s device RealTime H1N1 is approved only for the duration of the health emergency declared because of the spread of the virus. Roche’s test now joins Gen-Probe and Quest Diagnostics products on the U.S. market. When the emergency is declared over, Roche would have to re-apply for full marketing approval. (Click here for more)

“Roche Says FDA Grants Approval For Swine Flu Test” – BusinessWeek (AP) (11/16/09)

Hot Off the Presses: Medical Device Market 2009: Interventional Cardiology - This 86-page Special Report from IN VIVO identifies the most important trends in cardiology devices in recent years, teases out the critical decisions that drove those developments, and takes you behind the scenes and into the minds of the architects of these new technologies and business strategies. Find out more...