Study: Medical Device Tax Could Cost Jobs, Stifle Innovation

WASHINGTON,D.C. –The medical device tax, if implemented, could cost tens of thousands of jobs, almost double the industry’s total taxes, raise the effective tax rate to among the highest in the world, and harm U.S. competiveness, according to a study released today by the Advanced Medical Technology Association (AdvaMed).  The new study, “Employment Effects of the New Excise Tax on the Medical Device Industry,” by Manhattan Institute senior fellow Diana Furchtgott-Roth and Hudson Institute senior fellow Harold Furchtgott-Roth, outlines a number of economic harms likely to result from the tax.Continue reading

ASU to develop early diagnostics against colorectal cancer

Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Insitute's Center for Sustainable Health at Arizona State University

ASU’s Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou, Guangdong, China.

ASU, China’s Sun Yat-Sen University partner

Arizona State University and China’s Sun Yat-Sen University (SYSU) have formalized a research collaboration aimed at developing early and predictive diagnostics to improve patient outcomes for colorectal cancer.  ASU’s Leland Hartwell, Nobel laureate and chief scientist at the Biodesign Institute’s Center for Sustainable Health, spearheaded the agreement with Jianping Wang, director of the SYSU Gastrointestinal Institute of the Sixth Affiliated Hospital in Guangzhou, Guangdong, China.

“Recent advances in molecular technologies promise great improvements in medical care through prevention and early detection of disease,” Hartwell said.

Read more at ASU News

Should Germany be your medical device’s gateway to Europe

U.S. Commercial Service Webinar:  Germany –  Top Choice for U.S. Medical Technology

Date: Tuesday, September 13, 2011
Time: noon EDT/ 11 a.m. CDT/ 9 a.m. PDT
Place:  Online webinar on your computer
Fee: $75 per person

Join the U.S. Commercial Service’s webinar to gain expertise in using Germany as your gateway into the European Union as well as understanding the reimbursement challenges faced by American companies selling to the German Healthcare Market.  The German Healthcare Market is the largest in Europe.  It was 11.6 % of GDP (2009); employed 5.4 million people; and accounted for expenditures of € 278.3 billion in 2009.  According to the German Medical Technology Association (BVMed), the medical devices segment employed 170,000 and generated expenditures of
€ 25 billion in 2009.Continue reading

Intrinsic Bioprobes, Inc. Acquired by Thermo Fisher

Thermo Fisher Scientific Inc., the world leader in serving science, announced on September 1, 2011  that it has enhanced its workflow for biomarker research and diagnostics by acquiring Tempe, Arizona based  Intrinsic Bioprobes Inc., a manufacturer of unique immuno-enrichment, sample-preparation tools used in quantitative mass spectrometry. The Intrinsic Bioprobes portfolio enables Thermo Fisher to offer its worldwide life science research and clinical diagnostics customers an enhanced solution for quantitative protein biomarker detection.

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President Sander visits the University of Arizona’s Research Parks

University of Arizona President Eugene Sander Tours U of A Research Park on August 29, 2011(Tucson, Arizona)  On August 29, University of Arizona President Eugene Sander toured the University’s Research Parks.  The Office of University Research Parks supports the University of Arizona’s mission of education, research and outreach by utilizing research parks and business incubators to advance technology development, commercialization and business attraction. 

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Tips on Writing Powerful Public Comment Letters Regarding Proposed Regulations

By: Michael T. Hull – Managing Director, InVent Life Sciences   mhull@inventls.com  (Former Regional Advocate for the U.S. SBA Office of Advocacy)

The federal government proposes and finalizes approximately 4,000 new rules every year. In general approximately 800-1,000 will directly affect small business. A 2008 study by the U.S. Small Business Administration’s Office of Advocacy estimated that the cost of complying with federal rules and regulations exceeds $1.75 trillion per year with small businesses spending approximately 36% more per employee than their large business counterparts.Continue reading

Luceome Biotechnologies Receives $1.9 Million in Phase I and Phase II SBIR Funding to Advance its High Throughput Screening Platform

TUCSON, AZ – LUCEOME BIOTECHNOLOGIES a privately held biotechnology company focused on the discovery and development of its innovative proprietary assay platform today announced the award of $1.6 million in grant funding from The National Institutes of Health to further their research in high throughput screening using the KinaseSeeker™ technology. Earlier this year, Luceome was awarded a grant for $287K for research in the area of poly(ADP-ribose) detection.

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The FDA When There’s An App For That

There is a lot happening on the medical device front these days around MDDS (Medical Device Data Systems) and the FDA is paying close attention with new regulations, guidance and requests for comment. 

With the  April 2012 compliance deadline less than 8 months away, AZBio Member John C. Hoffman of QMR is paying close attention too and keeping our community in the loop via the AZBio  Resource Network Group on LinkedIn.  If you and your team are working in the MDDS space, you’ll want to get connected and join the discussion.

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