Most Clicked AdvaMed SmartBrief Stories
1. Ubl: Supreme Court's pre-emption ruling upholds federal law
AdvaMed SmartBrief | Oct 06, 2008
A recent editorial in The Boston Globe overstates the effect of the Supreme Court's ruling on pre-emption in the medical-device sector because the ruling does not shield companies from lawsuits, AdvaMed President and CEO Stephen J. Ubl writes in a letter to the editor. The decision upholds federal law, and an environment that supports varying safety standards for different states would hamper innovations and patient access to life-saving devices, Ubl writes. Boston Globe, The (10/06)
2. Lehman bankruptcy prompts Boston Scientific founders to sell shares
AdvaMed SmartBrief | Oct 10, 2008
New York Times, The (10/09)
3. Harvard receives donation worth $125M
AdvaMed SmartBrief | Oct 08, 2008
Harvard University has received a $125 million donation from Hansjörg Wyss, a Harvard alumnus and chairman of Swiss medical device maker Synthes. The university plans to rename and expand the Institute for Biologically Inspired Engineering, which will concentrate on areas including synthetic biology and biological materials. Wall Street Journal, The (subscription required) (10/08) Boston Globe, The (10/07)
4. Medtronic CEO: Patent-case win could boost sales of Endeavor stent
AdvaMed SmartBrief | Oct 07, 2008
Medtronic CEO William Hawkins said the company may increase its share of the $1.9 billion U.S. market for drug-coated stents if it wins a patent-infringement case against Abbott Laboratories over the rapid-exchange catheter. A favorable ruling would allow Medtronic to equip its Endeavor heart stent with the catheter, which is used in competing devices from Abbott, Boston Scientific and Johnson & Johnson, Hawkins said. Bloomberg (10/07)
5. FDA warns LabCorp for unapproved ovarian cancer test
AdvaMed SmartBrief | Oct 09, 2008
The FDA has issued a warning letter alleging that Laboratory Corporation of America marketed OvaSure -- a test designed to help detect early-stage ovarian cancer -- without securing approval. A LabCorp spokesman said the company was "disappointed" with the letter, but is in talks with the FDA. New York Times, The (10/08)
6. FDA will focus on devices with bisphenol A
AdvaMed SmartBrief | Oct 08, 2008
The FDA plans to release a document evaluating the safety of various FDA-regulated devices that contain bisphenol A, an agency spokesman said. The move comes in the wake of a draft report investigating how BPA can be transferred from food-contact materials. FDAnews (10/08)
7. Justice Department takes part in suit against McKesson, others
AdvaMed SmartBrief | Oct 07, 2008
The U.S. Justice Department joined a whistle-blower case against McKesson Corp. and several other firms over allegations that they filed fraudulent Medicare claims, paid unlawful kickbacks and set up phony medical-equipment suppliers. A McKesson spokesman said the drug wholesaler has been cooperating with the federal investigation for years and that "the case is without merit." Wall Street Journal, The (subscription required) (10/07)
8. NeuroMetrix to shut down office in Columbia, Md.
AdvaMed SmartBrief | Oct 08, 2008
Sun (Baltimore), The (free registration) (10/07)
9. Expert: FDA hopes to release ISO guidance by year's end
AdvaMed SmartBrief | Oct 10, 2008
The FDA has held off on issuing a proposed guidance that calls on medical-device makers to voluntarily present International Organization for Standards audit reports, but it hopes to push through with the release by the end of 2008, said an official with the agency's Center for Devices and Radiological Health. Under the FDA Amendments Act, the agency may use ISO audit reports as a basis in deciding which facilities to inspect. FDAnews (10/10)
10. Cyberdyne to rent out assistive-limb suit in Japan
AdvaMed SmartBrief | Oct 09, 2008
Cyberdyne is set on Friday to begin renting out its "hybrid assistive limb" -- a robotic suit designed for use in people with mobility problems -- in Japan for $2,200 per month. The battery-operated device uses sensors that can read and transmit brain signals to automated leg braces to help people walk. MSNBC (10/07)
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