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Company Agrees to Stop Making, Selling Imaging Devices
FDAnews - Monday, January 22, 2007
GE OEC Medical Systems, its parent company, General Electric (GE) — doing business as GE Healthcare — and two of GE’s top executives have signed an FDA consent decree of permanent injunction related to X-ray surgical imaging systems, the FDA said in a recent ... more

Medtronic Pulls Devices From U.S. Market; Competitors Could Benefit
FDAnews - Monday, January 22, 2007
Medtronic’s Physio-Control business has suspended U.S. shipments of external defibrillators and other products from its Redmond, Wash., facility in a move that could allow rival devicemakers to gain market ... more

FDA Warns Devicemaker for Multiple cGMP Failures
FDAnews - Monday, January 22, 2007
The FDA warned automatic external defibrillator (AED) maker MRL for several current good manufacturing practice (cGMP) violations and said the company’s devices are adulterated and ... more

Analysts Offer Market Outlook For U.S. Heart Device Firms
FDAnews - Monday, January 22, 2007
The success of the top U.S. heart-device manufacturers in 2007 will depend on the specific market forces individual firms are dealing with, analysts ... more

Full Issue in PDF format
FDAnews - Monday, January 15, 2007
View the entire issue in PDF ... more

FDA Program to Address Multiple Inspection Requirements May Not Work for All Firms
FDAnews - Monday, January 15, 2007
An FDA program that encourages eligible device firms to pay accredited organizations to conduct their inspections rather than having the FDA conduct inspections for free may work better for larger firms than smaller ones, according to a new ... more

Industry Wants FDA to Adopt Unified Standards for Combination Products
FDAnews - Monday, January 15, 2007
Because all FDA centers and various regulations are involved with combination products, whatever is happening with these devices will have an impact on all other products, said Mason Diamond, vice president of clinical and regulatory affairs for TyRx ... more

Full Issue in PDF format
FDAnews - Monday, December 18, 2006
View the entire issue in PDF ... more

Off-Label Stent Use May Be Restricted In Wake of FDA Meeting
FDAnews - Monday, December 18, 2006
After examining risks related to the off-label use of drug-eluting stents, an FDA panel has recommended the agency consider mandating labeling ... more

EU RETHINKING BAN ON MERCURY IN MEDICAL DEVICES
FDAnews - Sunday, December 17, 2006
In a slight concession to the medical device industry, the European Parliament last month agreed to delay a proposed ban on mercury-containing sphygmomanometers (blood pressure monitors) while the European Commission conducts a review into safe and reliable ... more


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President Boni Yayi Visits and Thanks the Peace Corps
allAfrica.com - Sunday, December 17, 2006
On a visit to the U.S. this week, newly-elected President Dr. Thomas Boni Yayi of the Republic of Benin made a special trip to meet with Peace Corps representatives and said he is looking to expand the partnership between Peace Corps and his ... more

US, Benin Presidents Discuss Darfur
Topix - Saturday, December 16, 2006
Stearns report - Download 343k Listen to Stearns report U.S. President George Bush says he will continue to work through the United Nations to strengthen an African Union peacekeeping force in Sudan's Darfur ... Comment ... more

Full Issue in PDF format
FDAnews - Thursday, December 14, 2006
View the entire issue in PDF ... more

THINKING OF DOING BUSINESS IN LATIN AMERICA? DO YOUR HOMEWORK FIRST
FDAnews - Thursday, December 14, 2006
Economic growth and a desire to improve the overall quality of and access to healthcare services should make Latin America an enticing market for medical device ... more

Christmas Season a Time to Heal Family Life, Says Bishop
allAfrica.com - Wednesday, December 13, 2006
Advent is an opportune time to "strengthen family bonds with the power of the Prince of Peace," Bishop Pascal N'Koué of the Diocese of Natitingou says in a pastoral letter to his ... more

President Bush to Welcome President Boni Yayi of the Republic of Benin to the White House
Topix - Saturday, December 09, 2006
President Bush will welcome President Boni Yayi of the Republic of Benin to the White House on December 14, 2006. Comment ... more

U.S. AND JAPAN IMPLEMENT PROGRAM TO SPEED DEVICE APPROVALS
FDAnews - Friday, December 08, 2006
The U.S. and Japan want to remove barriers to timely medical device approvals through the "Harmonization by Doing" (HBD) initiative, aimed at developing common protocols for premarket clinical studies of new cardiovascular ... more

SENATE PASSES BILL TO SET MEDICAL IMAGING STANDARDS
FDAnews - Friday, December 08, 2006
The Senate passed Sen. Mike Enzi's (R-Wyo.) "Consumer Assurance of Radiologic Excellence Act," S.2322, by unanimous consent Dec. ... more

FDA PANEL MEETS TO DISCUSS LIPID DIAGNOSTIC ASSAY
FDAnews - Friday, December 08, 2006
The FDA's Clinical Chemistry and Clinical Toxicology Devices Panel met Dec. 6 to hear recommendations regarding the validity of lipid subfraction diagnostic assays to show patients' risk of cardiovascular disease ... more

Two Journalists Sentenced to Six Months in Prison With No Parole for "Defamation"
allAfrica.com - Wednesday, December 06, 2006
Reporters Without Borders expressed shock at a six-month prison sentence handed down to publisher Clément Adéchian and editor Cécil Adjévi, of the privately-owned daily "L'Informateur", together with a fine of 500,000 FCFA (752 euros) for ... more

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