Biomedical Market Newsletter articles from December 2002

Biomedical Market Newsletter archives from December 2002

Reused medical devices pose health & safety risk to patients: survey shows doctors, nurses oppose practice & most consumers are unaware. (Breaking News ...).
December 23, 2002... On Dec. 5, 2002, the Center for Patient Advocacy released a survey of surgeons, operating room nurses and consumers which reveals that health care professionals have grave concerns about the reuse of single use medical devices, and their impact...

Frequently-asked-questions about the reprocessing & reuse of single-use devices by third-party & hospital reprocessors: 2 additional questions; final guidance for industry & FDA staff. (Breaking News ...).
December 23, 2002... Dec. 11, 2002 This document provides two additional questions to the FDA'S Frequently-Asked-Questions about the Reprocessing & Reuse of Single-Use Devices by Third Party & Hospital Reprocessors; Final Guidance for Industry and FDA Staff,...

President Bush announces smallpox plan. (Breaking News ...).
December 23, 2002... Dec. 13, 2002 -- President Bush, standing with DHHS Sec. Tommy G. Thompson and other Cabinet members and advisorsat the White House, announced a plan to protect the American people against the threat of smallpox attack by hostile groups or...

Syncor Taiwan Inc pleads guilty to violating foreign corrupt practices act & agrees to maximum fine. (Breaking News).
December 23, 2002... DEC. 10, 2002 -- WASHINGTON DC--Michael Chertoff, Assistant Attorney General for the US Department of Justice, Criminal Division, and Debra W. Yang, US Attorney for the Central District of California, announced today the guilty plea of Syncor...

US Justice Dept Antitrust Div to co-host hearings on Health Care Competition Law & Policy. (Breaking News).
December 23, 2002... NOV. 7, 2002 -- WASHINGTON DC -- Asst Attorney General Charles A. James announced today that the Antitrust Div of the US Dept of Justice will hold hearings on Health Care Competition Law and Policy, beginning in Feb. 2003. The hearings, to...

US Justice Dept accuses 27 top hospitals of mischarging Medicare: experimental cardiac devices are involved former devices salesperson blows the whistle. (Breaking News).
December 23, 2002... DEC. 17, 2002 -- WASHINGTON DC -- The United States has intervened in dozens of lawsuits alleging that some of the country's most prestigious hospitals mischarged the Medicare program, the US Justice Department announced today. The suits allege...

DHHS announces pilot tests to measure quality of US hospitals. (Breaking News).
December 23, 2002... DEC. 12, 2002 -- WASHINGTON DC -- DHHS Secretary Tommy G. Thompson applauded the nation's hospital leadership for new steps they announced toward providing public information on quality of care, and he joined in calling on hospitals throughout...

US DHHS moves to focus regs on improved care: advisory panel issues final report with 225 recommendations that bolsters reform efforts. (Breaking News).
December 23, 2002... NOV. 21, 2002 -- WASHINGTON DC -- DHHS' Advisory Committee on Regulatory Reform today issued its final report highlighting hundreds of specific recommendations for improving regulatory requirements across DHHS agencies--including many that DHHS...

The international promise of biotech. (Guest Editorial).
December 23, 2002... 2002 BioIreland Conference Dublin Ireland Nov. 15, 2002 (edited & condensed version of his speech) Those of you here at the BioIreland 2002 conference are leaders in commerce, industry and biotechnology, but more than that, you are...

ATS Medical, Inc. (NASDAQ: ATSI).
December 23, 2002... MINNEAPOLIS MN -- Michael D. Dale, President & CEO, announced that Richard A. Curtis is its new VP of Marketing & Business Development, and was previously VP of Corporate Development, at Cardinal Health, Inc. Also, Kevin A. Petersen has assumed...

Aventis Pasteur (NYSE:AVE).
December 23, 2002... LYON FRANCE -- David J. Williams is its new Chairman/ Pres/CEO, succeeding Jean-Jacques Bertrand.

Celera Genomics (NYSE:CRA).
December 23, 2002... ROCKVILLE MD -- James P. Yee, M.D., Ph.D., has been appointed Head of Development, reporting to Robert Booth, Ph.D., SR VP of R&D.

Endologix, Inc. (NASDAQ:ELGX).
December 23, 2002... IRVINE CA -- Paul McCormick has been appointed CEO, in addition to his position as President. Current Endologix Chairman & CEO Franklin D. Brown has been named Executive Chairman of the Board.

GenVec, Inc. (NASDAQ: GNVC).
December 23, 2002... GAITHERSBURG MD -- David P. Wright has been appointed as President & COO, after serving as President & Chief Business Officer for Guilford Pharmaceuticals (Baltimore MD), announced Dr. Paul H. Fischer, GenVec's CEO.

HemaCare Corp (OTC/BB:HEMA.OB).
December 23, 2002... LOS ANGELES CA -- Judi Irving, CPA, new Pres/ CEO, from the same positions at Health Net of AZ/ OR, announced Jay Steffenhagen, Chairman.

Interpore Cross International (NASDAQ:BONZ).
December 23, 2002... IRVINE CA -- Robert Cripe, new VP Marketing & Development for its minimally invasive surgery products.

Medical Device Manufacturers Association (nonprofit).
December 23, 2002... WASHINGTON DC -- Mark B. Leahey, Esq., to Executive Director, from Dir of Federal Affairs, succeeding Larry Holden, said Paul Touhey, MDMA Board Chairman.

OmniSonics Medical Technologies (privately-held).
December 23, 2002... WILMINGTON MA -- Neil Magner is its new VP of Operations, said Robert A. Rabiner, President & CEO.

Parenteral Drug Association (nonprofit).
December 23, 2002... BALTIMORE MD -- Robert J. Mello, Ph.D., has joined as VP of Education and Director of PDA's Training & Research Institute, from RJM Pharmaceutical Consultants where he was President.

University of California, San Diego (nonprofit).
December 23, 2002... SAN DIEGO CA -- Jack Dixon, Ph.D., Director of the Life Sciences Institute at the University of Michigan and one of the world's leading biological chemists, has been recruited to serve as Dean for Scientific Affairs, Health Sciences at UCSD.

Keynote address by the New FDA Commissioner. (Guest Editorial).
December 23, 2002... Health Services & Outcomes Research Conference Baker Institute at Rice University Houston TX USA Nov. 25, 2002. I want to begin with an apology for false advertising. As you may know, this is an important issue for FDA. When you...

Medical devices & supplies industry market update. (Market Research Studies).(Industry Overview)
December 23, 2002... Oct. 10, 2002 US Department of Health & Human Services Centers for Medicare & Medicaid Services Washington DC USA INTRODUCTION As the regulators of over $500 bln per year of Medicare, Medicaid, and S-CHIP funds, we believe it...

FDA releases clarification on 510(k) fees for FY 2003. (Market Research Studies).
December 23, 2002... DEC. 23, 2002 -- Certain language in FDA's November 21, 2002 Federal Register Notice, 67 F.R. 70228, may confuse some persons concerning the fee that must be paid by a small business that submits a 510(k) premarket notification for FDA review...

5% of doctors are responsible for half of all medical malpractice. (Guest Editorial).
December 23, 2002... Public Citizen Health Research Group Washington DC Just 5% of American doctors are responsible for half the malpractice in the US, according to a new analysis of federal data by the consumer group Public Citizen. "The medical...

Medical device user fee performance goals detailed for 2003: 510(k) substantially equivalent devices, instruments, equipment & supplies to receive improved review times. (Breaking News).
December 27, 2002... Details of the performance goals and procedures of the Medical Device User Fee & Modernization Act of 2002, "MDUFMA," which accompany the authorization for the fees, were released earlier this month to the industry and public. These goals...

Medical Industry Directory of Associations & Organizations--2003[TM]: Part 1--4th Annual Edition.
December 27, 2002... Lists over 2,600 medical associations & business development organizations (400 more than last year) in 110 countries worldwide, as well as privately-held businesses that host seminars & conferences. Published exclusively by: ...

FDA acts to strengthen controls on imports of certain drugs: FDA Commissioner McClellan says a major FDA priority is reducing preventable adverse events. (Breaking News).
December 31, 2002... On Dec. 9, 2002, as part of its ongoing efforts to reduce preventable adverse events from the products it regulates, the US Food & Drug Administration (FDA) announced that it is strengthening the controls that are designed to protect patients,...

Medical Industry Directory of Associations & Organizations--2003[TM]: Part 2 of 2--4th Annual Edition.
December 31, 2002... Lists over 2,600 medical associations & business development organizations (400 more than last year) in 110 countries worldwide, as well as privately-held businesses that host seminars & conferences. Published exclusively by: ...

History of the US Food & Drug Administration. (Market Research Studies).
December 31, 2002... The US Food & Drug Administration is a scientific, regulatory, and public health agency that oversees items accounting for 25 cents of every dollar spent by consumers. Its jurisdiction encompasses most food products (other than meat and...

Milestones in US Food & Drug Law history. (Market Research Studies).
December 31, 2002... From the beginnings of civilization people have been concerned about the quality and safety of foods and medicines. In 1202, King John of England proclaimed the first English food law, the Assize of Bread, which prohibited adulteration of bread...

The story of the laws behind the labels. (Market Research Studies).
December 31, 2002... How old is the FDA? There are two answers to this frequent question: as a law enforcement organization its 75th anniversary year is 1981, but as a scientific institution it dates from 1862 when Charles M. Wetherill, first chemist of the new...