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GLG News by Medical Device Experts

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August 4, 2008
FDA Restrictions on ESA's Will Have Minimal Effect of EPO Usage.
Analysis of: Amgen Told to Reword Drug Label | www.nytimes.com
Author: Joe Atkins, Chief Executive Officer, Medical Concepts & Innovations
1)  Concerns over the new FDA restrictions on ESA's is being overstated. 2)  Amgen will continue to do well in the ESA market place, in spite of these changes. 3)  J&J will receive the brunt of these changes, strictly because of their market concentration in the oncology market. 4) ...
August 4, 2008
Veterans Admininstration Sets The Standard for Electronic Medical Records: Why Re-invent The Wheel?
Analysis of: Nationwide EHR Implementation Price Tag Estimated at $150 billion | www.govhealthit.com
Author: Joe Atkins, Chief Executive Officer, Medical Concepts & Innovations
The VA has already won many awards for an electronic medical records system, which tax payers have already paid for. Adopting the VA "CPRS" program would save the taxpayers and the private sector hundreds of billions of dollars.
Ken PowellJuly 28, 2008
New blood-based test for colorectal cancer
Analysis of: GeneNews begins marketing ColonSentry colorectal cancer screening test | www.labnews.com
Author: Ken Powell, President, Genesis Business Development
A non-invasive, DNA-based screening test for colon cancer could significantly increase the 90MM US adults over 50 that should participate in colorectal cancer screening.  Colon cancer is responsible for approximately 57,000 deaths in the US each year and account for 9% of all cancer deaths. ...
Ken PowellJuly 24, 2008
New Developments in Sepsis Diagnostics
Analysis of: SIRS-Lab Pre-Announces Biomarker Based Sepsis Test | www.medcompare.com
Author: Ken Powell, President, Genesis Business Development
Severe sepsis is a major cause of death in the US.  Annual mortality rates of over 215,000 patients exceed those for acute myocardial infarction and leading cancers.  A sensitive and specific marker could relieve the huge medical and financial burden created by the 750,000 cases of sepsis...
Ken PowellJuly 15, 2008
Infectious Diseases
Analysis of: BD Diagnostics' GeneOhm Cdiff test receives CE mark for rapid diagnosis of Clostridium difficile infection | www.labnews.com
Author: Ken Powell, President, Genesis Business Development
BD GeneOhm's recent CE Mark for its molecular diagnostic test for the rapid diagnosis of Clostridium difficile infection will likely intensify the competition between BD and Cepheid.  Both companies market tests for the $1 billion dollar Methicillin-Resistant Staphylococcus Aureus (MRSA)&...
Ken PowellJuly 15, 2008
Novel Test for Appendicitis
Analysis of: AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM) Appendicitis Blood Test | www.medcompare.com
Author: Ken Powell, President, Genesis Business Development
A new test form AspenBio could revolutionalize the diagnosis of appendicitis.  Over 6 million patients present to Emergency Departments each year with abdominal pain, resulting in approximately 700,000 appendectomies.  Over $5 billion is spent each year in the US on CT scans, the currently...
Ken PowellJuly 11, 2008
Competitive Bidding Demo Repealed by House of Representatives
Analysis of: Federal Judge Hands Labs a Win: Issues Order to Stop Medicare Lab Bid Demo! | www.darkdaily.com
Author: Ken Powell, President, Genesis Business Development
The House of Representatives repealed the Centers for Medicare and Medicaid Services (CMS) authority to conduct a competitive bidding demonstration program for laboratory services.  Senate action is now required.
June 10, 2008
No Company is Bullet-Proof Against Federal Contractor Risks
Analysis of: U.S. sues Honeywell over bullet-proof vests | www.latimes.com
Author: James O'Reilly, Volunteer Professor of Law, University of Cincinnati - CC
Product liability exposure of new materials makers can be severe, especially with fatal consequences of failures Internal memos re product problems can shoot company in the foot; prudent firms have a plan for controlling open-ended speculative memos in an instant-message environment Major PR and govt....
Ken PowellJune 5, 2008
Datascope Benefits from Sale of Patient Monitoring Business
Analysis of: Datacsope stock soars on takeover tlaks | www.northjersey.com
Author: Ken Powell, President, Genesis Business Development
The sale of Datascope's (NASDAQ: DSCP) patient monitoring business earlier this year to Mindray Medical (NYSE: MR) has resulted in several acquisition offers from unnamed companies.  On Wednesday, Datascope's stock increased 11% in response to this news.   
Ken PowellMay 19, 2008
Mindray Completes Acquisition of Datascope's Patient Monitoring Business
Analysis of: Mindray Medical Completes Acquisition of Datascope's Patient Monitoring Business | biz.yahoo.com
Author: Ken Powell, President, Genesis Business Development
Mindray Medical International (NYSE: MR) has completed its acquisition of Datascope Corporation's (NASDAQ: DSCP) patient monitoring business for $209MM (US).  This acquisition brings both opportunities and challenges for one of the fastest growing global healthcare companies in ...

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